ClinicalTrials.gov

History of Changes for Study: NCT04381650
A Study of TAK-981 Given With Pembrolizumab in Participants With Select Advanced or Metastatic Solid Tumors
Latest version (submitted March 21, 2024) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 6, 2020 None (earliest Version on record)
2 June 8, 2020 Study Status
3 July 7, 2020 Recruitment Status, Study Status and Contacts/Locations
4 July 14, 2020 Study Status
5 July 30, 2020 Study Status
6 August 19, 2020 Study Status
7 September 14, 2020 Study Status and Contacts/Locations
8 October 6, 2020 Study Status and Contacts/Locations
9 October 13, 2020 IPDSharing, Contacts/Locations and Study Status
10 July 16, 2021 Contacts/Locations, Outcome Measures, Arms and Interventions, Study Description, Study Status, Study Identification, Eligibility and Study Design
11 January 26, 2022 Outcome Measures, Contacts/Locations, Study Status, Eligibility, Arms and Interventions, Study Description and Study Identification
12 September 13, 2022 Study Status, Arms and Interventions, Outcome Measures, References, Eligibility, Study Design and Study Description
13 January 31, 2023 Contacts/Locations and Study Status
14 March 1, 2023 Study Status
15 March 7, 2023 Contacts/Locations and Study Status
16 April 4, 2023 Contacts/Locations and Study Status
17 April 27, 2023 Contacts/Locations and Study Status
18 June 8, 2023 Contacts/Locations and Study Status
19 August 8, 2023 Contacts/Locations, Outcome Measures, Arms and Interventions, Study Status, Eligibility, Study Design, Conditions and Study Description
20 September 12, 2023 Contacts/Locations and Study Status
21 October 23, 2023 Study Status and Contacts/Locations
22 February 1, 2024 Contacts/Locations and Study Status
23 March 21, 2024 Recruitment Status, Contacts/Locations, Study Status and Study Design
Comparison Format:

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Changes (Merged) for Study: NCT04381650
February 1, 2024 (v22) -- March 21, 2024 (v23)

Changes in: Study Status, Study Design and Contacts/Locations

Open or close this module Study Identification
Unique Protocol ID: TAK-981-1502
Brief Title: A Study of TAK-981 Given With Pembrolizumab in Participants With Select Advanced or Metastatic Solid Tumors
Official Title: A Phase 1b/2 Study of TAK-981 Plus Pembrolizumab to Evaluate the Safety, Tolerability, and Antitumor Activity of the Combination in Patients With Select Advanced or Metastatic Solid Tumors
Secondary IDs: 2020-004325-23 [EudraCT Number]
jRCT2031210417 [Registry Identifier: jRCT]
Open or close this module Study Status
Record Verification: February 2024 March 2024
Overall Status: Recruiting Active, not recruiting
Study Start: August 17, 2020
Primary Completion: November 30, 2025 [Anticipated]
Study Completion: November 30, 2025 [Anticipated]
First Submitted: May 6, 2020
First Submitted that
Met QC Criteria:
May 6, 2020
First Posted: May 11, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
February 1, 2024 March 21, 2024
Last Update Posted: February 2 March 22, 2024 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Takeda
Responsible Party: Sponsor
Collaborators: Takeda Development Center Americas, Inc.
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary:

TAK-981 is being tested in combination with pembrolizumab to treat participants who have select advanced or metastatic solid tumors.

The study aims are to evaluate the safety, tolerability, and preliminary efficacy of TAK-981 in combination with pembrolizumab.

Participants will be on this combination treatment for 21-day cycles. They will continue with this treatment for up to 24 months or until participants meet any discontinuation criteria.

Detailed Description:

The drug being tested in this study is called TAK-981. TAK-981 is being tested to treat people who have select advanced or metastatic solid tumors. The study will include a dose escalation phase and a dose expansion phase.

The study will enroll approximately 231 participants, approximately 32 participants in the dose escalation phase 1 and approximately 76 to 199 participants in the 8 cohorts of dose expansion phase 2. Participants will receive escalating doses of TAK-981 and fixed dose of pembrolizumab until recommended phase 2 dose (RP2D) is determined:

• Dose Escalation: TAK-981 + Pembrolizumab (Fixed Dose)

Once Phase 2 doses are identified, participants of select advanced or metastatic solid tumors will receive TAK-981 in below defined cohorts in the expansion phase 2:

  • Dose Expansion Phase: Cohort A: Non-squamous Non-small Cell Lung Cancer (NSCLC)
  • Dose Expansion Phase: Cohort B: Cervical Cancer
  • Dose Expansion Phase: Cohort C: Microsatellite Stable Colorectal Cancer (MSS-CRC)
  • Dose Expansion Phase: Cohort D: Cutaneous Melanoma
  • Dose Expansion Phase: Cohort E: Squamous NSCLC
  • Dose Expansion Phase: Cohort F: Checkpoint Inhibitors (CPI) Refractory Squamous or Nonsquamous NSCLC

This multi-center trial will be conducted worldwide. The overall time to participate in this study is 60 months. Participants will make multiple visits to the clinic, and progression-free survival follow-up for maximum up to 12 months after last dose of study drug.

Open or close this module Conditions
Conditions: Advanced or Metastatic Solid Tumors
Keywords: Drug Therapy
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1/Phase 2
Interventional Study Model: Sequential Assignment
This study has 2 Phases. Phase 1 is dose escalation phase with sequential drug assignment. Phase 2 is parallel assignment.
Number of Arms: 7
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 231 [Anticipated] 49 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Dose Escalation: TAK-981 + Pembrolizumab (Fixed Dose)
Escalating doses of TAK-981 with starting dose of 40 mg, intravenous (IV) infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 or Days 1, 8 and 15 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until RP2D is determined (for a maximum of 24 months).
Drug: TAK-981
TAK-981 IV infusion.
Drug: Pembrolizumab
Pembrolizumab IV infusion.
Experimental: Dose Expansion Phase: Cohort A: Non-squamous NSCLC
TAK-981 as IV infusion in participants with non-squamous non-small cell lung cancer (NSCLC) on Days 1, 4, 8 and 11 or Days 1 and 8 or Days 1, 8 and 15 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.
Drug: TAK-981
TAK-981 IV infusion.
Drug: Pembrolizumab
Pembrolizumab IV infusion.
Experimental: Dose Expansion Phase: Cohort B: Cervical Cancer
TAK-981 as IV infusion in participants with cervical cancer on Days 1, 4, 8 and 11 or Days 1 and 8 or Days 1, 8 and 15 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.
Drug: TAK-981
TAK-981 IV infusion.
Drug: Pembrolizumab
Pembrolizumab IV infusion.
Experimental: Dose Expansion Phase: Cohort C: MSS-CRC
TAK-981 as IV infusion in participants with microsatellite stable colorectal cancer (MSS-CRC) on Days 1, 4, 8 and 11 or Days 1 and 8 or Days 1, 8 and 15 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.
Drug: TAK-981
TAK-981 IV infusion.
Drug: Pembrolizumab
Pembrolizumab IV infusion.
Experimental: Dose Expansion Phase: Cohort D: Cutaneous Melanoma
TAK-981 as IV infusion in participants with cutaneous melanoma on Days 1, 4, 8 and 11 or Days 1 and 8 or Days 1, 8 and 15 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.
Drug: TAK-981
TAK-981 IV infusion.
Drug: Pembrolizumab
Pembrolizumab IV infusion.
Experimental: Dose Expansion Phase: Cohort E: Squamous NSCLC
TAK-981 as IV infusion in participants with squamous non-small cell lung cancer (NSCLC) on Days 1, 4, 8 and 11 or Days 1 and 8 or Days 1, 8 and 15 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.
Drug: TAK-981
TAK-981 IV infusion.
Drug: Pembrolizumab
Pembrolizumab IV infusion.
Experimental: Dose Expansion Phase: Cohort F: CPI Refractory Squamous or Nonsquamous NSCLC
TAK-981 as IV infusion in participants with checkpoint inhibitors (CPI) refractory squamous or nonsquamous NSCLC on Days 1, 4, 8 and 11 or Days 1 and 8 or Days 1, 8 and 15 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.
Drug: TAK-981
TAK-981 IV infusion.
Drug: Pembrolizumab
Pembrolizumab IV infusion.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Phase 1: Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs)
[ Time Frame: Up to 48 months ]

An adverse event (AE) is any untoward medical occurrence in a participant administered a medicinal investigational drug. The untoward medical occurrence does not necessarily have to have a causal relationship with treatment. A TEAE is defined as an AE that occurs after administration of first dose of study drug and through 30 days after last dose of study drug or until start of subsequent antineoplastic therapy. AEs will be evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0 except cytokine release syndrome (CRS), will be graded according to American society for transplantation and cellular therapy (ASCST) Consensus Grading for CRS.
2. Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs)
[ Time Frame: Up to Cycle 1 (each cycle is of 21 days) ]

DLTs will be evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0 except cytokine release syndrome (CRS), will be graded according to American society for transplantation and cellular therapy (ASCST) Consensus Grading for CRS.
3. Phase 1: Number of Participants With Grade 3 or Higher Treatment Emergent Adverse Events (TEAEs)
[ Time Frame: Up to 48 months ]

4. Phase 1: Number of Participants With One or More Serious Adverse Events (SAEs)
[ Time Frame: Up to 48 months ]

An SAE is any untoward medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongation of present hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect or is a medically important event that may not be immediately life-threatening or result in death or hospitalization, but may jeopardize the participant or may require intervention to prevent one of other outcomes listed in definition above, or involves suspected transmission via a medicinal product of an infectious agent.
5. Phase 1: Number of Participants with One or More TEAEs Leading to Dose Modifications and Treatment Discontinuation
[ Time Frame: Up to 48 months ]

6. Phase 1: Number of Participants With Clinically Significant Laboratory Values
[ Time Frame: Up to 48 months ]

Laboratory parameters includes parameters of clinical chemistry, hematology, and urinalysis.
7. Phase 2: Overall Response Rate (ORR) as Assessed by the Investigator According to RECIST, Version 1.1
[ Time Frame: Up to 60 months ]

ORR is defined as the percentage of participants who achieve Complete Response (CR) and Partial Response (PR) (determined by the investigator) during the study according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
Secondary Outcome Measures:
1. Phase 1: Cmax: Maximum Observed Plasma Concentration for TAK-981
[ Time Frame: Cycle 1 (each cycle is 21 days) Days 1 and 8 pre-dose and at multiple timepoints (Up to 24 hours); Days 4 and 11: at the end of infusion; Cycle 2, Days 1 and 8, at the end of infusion and at 2 hours post-dose ]

2. Phase 1: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-981
[ Time Frame: Cycle 1 (each cycle is 21 days) Days 1 and 8 pre-dose and at multiple timepoints (Up to 24 hours); Days 4 and 11: at the end of infusion; Cycle 2, Days 1 and 8, at the end of infusion and at 2 hours post-dose ]

3. Phase 1: AUCt: Area Under the Plasma Concentration-time Curve from Time 0 to Time t Over the Dosing Interval for TAK-981
[ Time Frame: Cycle 1 (each cycle is 21 days) Days 1 and 8 pre-dose and at multiple timepoints (Up to 24 hours); Days 4 and 11: at the end of infusion; Cycle 2, Days 1 and 8, at the end of infusion and at 2 hours post-dose ]

4. Phase 1: AUC∞: Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for TAK-981
[ Time Frame: Cycle 1 (each cycle is 21 days) Days 1 and 8 pre-dose and at multiple timepoints (Up to 24 hours); Days 4 and 11: at the end of infusion; Cycle 2, Days 1 and 8, at the end of infusion and at 2 hours post-dose ]

5. Phase 1: t1/2z: Terminal Disposition Phase Half-life for TAK-981
[ Time Frame: Cycle 1 (each cycle is 21 days) Days 1 and 8 pre-dose and at multiple timepoints (Up to 24 hours); Days 4 and 11: at the end of infusion; Cycle 2, Days 1 and 8, at the end of infusion and at 2 hours post-dose ]

6. Phase 1: CL: Total Clearance After Intravenous Administration for TAK-981
[ Time Frame: Cycle 1 (each cycle is 21 days) Days 1 and 8 pre-dose and at multiple timepoints (Up to 24 hours); Days 4 and 11: at the end of infusion; Cycle 2, Days 1 and 8, at the end of infusion and at 2 hours post-dose ]

7. Phase 1: Vss: Volume of Distribution at Steady State After Intravenous Administration for TAK-981
[ Time Frame: Cycle 1 (each cycle is 21 days) Days 1 and 8 pre-dose and at multiple timepoints (Up to 24 hours); Days 4 and 11: at the end of infusion; Cycle 2, Days 1 and 8, at the end of infusion and at 2 hours post-dose ]

8. Phases 1 and 2: ORR as Defined by the Investigator According to Modified RECIST, Version 1.1 for Immune-Based Therapeutics (iRECIST) Modification
[ Time Frame: Up to 60 months ]

9. Phases 1 and 2: Disease Control Rate (DCR)
[ Time Frame: Up to 60 months ]

DCR is defined as the percentage of participants who achieve stable disease (SD) or better (CR+PR+SD determined by the investigator) during the study.
10. Phases 1 and 2: Durable Response Rate (DRR)
[ Time Frame: Up to 60 months ]

DRR is defined as the rate of objective responses (CR + PR) maintained for at least 6 months initiating at any time within 12 months of commencing therapy.
11. Phases 1 and 2: Duration of Response (DOR)
[ Time Frame: Up to 60 months ]

DOR is defined as a time from the time of first documentation of tumor response to the first recorded occurrence of disease progression (PD) or death from any cause (whichever occurs first), through end of study (up to approximately 60 months).
12. Phases 1 and 2: Progression-free Survival (PFS)
[ Time Frame: Up to 60 months ]

PFS is defined as time from the date of the first dose administration to the date of first documentation of PD or death due to any cause whichever occurs first, through the end of the study (up to approximately 60 months).
13. Phases 1 and 2: Time to Response (TTR)
[ Time Frame: Up to 60 months ]

TTR is defined as time from the date of the first dose administration to the date of first documented PR or better (up to approximately 60 months).
14. Phases 1 and 2: Time to Progression (TTP)
[ Time Frame: Up to 60 months ]

TTP is defined as the from the date of the first dose administration to the date of the first documentation of PD as defined by standard disease criteria.
15. Phase 2: Overall Survival (OS)
[ Time Frame: Up to 60 months ]

OS is defined as the time from the date of the first dose administration to the date of death. Participants without documentation of death at the time of analysis will be censored at the date last known to be alive.
16. Phase 1: Percentage of Participants at Each Dose Level Demonstrating Adduct Formation in Blood
[ Time Frame: Up to 48 months ]

TAK-981-small ubiquitin-like modifier (SUMO) adduct formation in blood will be evaluated.
17. Phase 1: Percent Change in Small Ubiquitin-like Modifier (SUMO) 2/3 Signal With Pre and Post-dose in Blood
[ Time Frame: Up to 48 months ]

SUMO pathway inhibition in blood will be evaluated.
18. Phase 2: Percentage of Participants With One or More Treatment Emergent Adverse Events (TEAEs)
[ Time Frame: Up to 60 months ]

19. Phase 2: Number of Participants With Grade 3 or Higher Treatment Emergent Adverse Events (TEAEs)
[ Time Frame: Up to 60 months ]

20. Phase 2: Number of Participants with One or More TEAEs Leading to Dose Modifications and Treatment Discontinuation
[ Time Frame: Up to 60 months ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  1. Has a histologically or cytologically documented, advanced (metastatic and/or unresectable) cancer as listed below that is incurable: Note: Prior neoadjuvant or adjuvant therapy included in initial treatment may not be considered first- or later-line standard of care treatment unless such treatments were completed less than 12 months prior to the current tumor recurrence.

    A. Non-squamous NSCLC for which prior standard first-line treatment containing an anti-programmed cell death protein 1/programmed cell death protein 1 ligand (PD-1/PD-L1) checkpoint inhibitor (CPI) alone or in combination has failed and that has progressed on no more than 1 prior systemic therapy. In Phase 2, participants with nonsquamous NSCLC must have not received more than 1 prior systemic therapy and must not have presented with disease progression during the first 6 months of treatment with first-line CPI/anti-PD-(1/L1)-containing therapy.

    Note: In Phase 1, participants with nonsquamous NSCLC and known driver mutations/genomic aberrations (e.g., epidermal growth factor receptor (EGFR), B-Raf proto-oncogene mutation V600E [BRAF V600E], and ROS proto-oncogene 1 [ROS1] sensitizing mutations, neurotrophic receptor tyrosine kinase [NRTK] gene fusions, and anaplastic lymphoma kinase [ALK] rearrangements) must have also shown progressive disease after treatment with a commercially available targeted therapy. In Phase 2, participants with driver mutations are not eligible.

    B. CPI-naive cervical cancer (squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma of the cervix) participants for whom prior standard first-line treatment has failed and who have received no more than 1 prior systemic line of therapy for recurrent or Stage IVB cervical cancer. Note: The following cervical tumors are not eligible: minimal deviation/adenoma malignum, gastric-type adenocarcinoma, clear-cell carcinoma, and mesonephric carcinoma. Histologic confirmation of the original primary tumor is required via pathology report. Note: First-line treatment must have consisted of platinum-containing doublet. Chemotherapy administered concurrently with primary radiation (e.g., weekly cisplatin) is not counted as a systemic chemotherapy regimen.

    C. CPI-naïve microsatellite stable-colorectal cancer (MSS-CRC) participants for whom prior standard first-line treatment has failed and who have progressed on no more than 3 chemotherapy regimens.

    Note: Participants must have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-containing regimens if indicated.

    D. Unresectable Stage III or Stage IV cutaneous melanoma that has not received prior therapy in the metastatic setting.

    Note: Participants with acral melanoma are not eligible. Participants who have presented with disease relapse after ≥6 months of the last dose of CPI or BRAF-mitogen-activated protein kinase kinase (MEK) inhibitor in the adjuvant setting are eligible.

    E. Squamous NSCLC for which prior standard first-line treatment containing an anti-PD-(1/L1) checkpoint inhibitor alone or in combination has failed. Participant must have not received more than 1 prior systemic therapy and must not have presented with disease progression during the first 6 months of treatment with first-line CPI/anti-PD-(1/L1)-containing therapy.

    F. Squamous or nonsquamous NSCLC for which prior standard first-line treatment containing an anti-PD-(1/L1) checkpoint inhibitor alone or in combination has failed within 6 months from the initiation of the CPI. Participants must not have received more than 1 prior systemic therapy in the metastatic setting.

    Note: Participants with driver mutations are not eligible.

  2. Has at least 1 radiologically measurable lesion based on RECIST, Version 1.1. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
  3. Has a performance status of 0 or 1 on the Eastern Cooperative Group Oncology (ECOG) Performance Scale.
  4. Has left ventricular ejection fraction (LVEF) ≥40%; as measured by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scan.
  5. Has recovered to Grade 1 or baseline from all toxicity associated with previous therapy or have the toxicity established as sequela. Note: Has a neuropathy ≤Grade 2, any grade alopecia, or autoimmune endocrinopathies with stable replacement therapy are permitted.
  6. Demonstrate adequate organ function as described below:

A. Platelet count ≥75.0 × 10^9/L. B. Absolute neutrophil count (ANC) ≥1.0 × 10^9/L. C. Hemoglobin ≥85 g/L (red blood cell [RBC] transfusion allowed ≥14 days before assessment).

D. Calculated creatinine clearance ≥30 mL/min using the Cockcroft-Gault formula.

E. Aspartate aminotransferase (AST, GOT) and alanine aminotransferase (ALT, GPT) ≤3.0 times the upper limit of normal (ULN), <5.0 times the ULN if liver enzyme elevations are due to liver metastases; bilirubin ≤1.5 times the ULN. Participants with Gilbert's syndrome may have a bilirubin level >1.5 times the ULN, per discussion between the investigator and the medical monitor.

Exclusion Criteria:

  1. History of uncontrolled brain metastasis (evidence of progression by imaging over a period of 4 weeks and/or neurologic symptoms that have not returned to baseline). Participant with treated brain metastases are allowed provided they are radiologically stable, without evidence of progression for at least 4 weeks by repeat imaging, clinically stable, and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment. Note: For asymptomatic participants, screening brain imaging is not required.
  2. Second malignancy within the previous 3 years, except treated basal cell or localized squamous skin carcinomas, localized prostate cancer, cervical carcinoma in situ, resected colorectal adenomatous polyps, breast cancer in situ, or other malignancy for which the participant is not on active anticancer therapy.
  3. Major surgery ≤14 days from the first dose of study drug and not recovered fully from any complications from surgery.
  4. History of immune-related AEs related to treatment with immune CPIs that required treatment discontinuation.
  5. Receiving or requires the continued use of medications that are known to be strong or moderate inhibitors and inducers of cytochrome P-450 (CYP) 3A4/5 and strong P-glycoprotein (Pgp) inhibitors.
  6. Baseline prolongation of the QT interval corrected using Fridericia's formula (QTcF) (e.g., repeated demonstration of QTcF interval >480 milliseconds (ms), history of congenital long QT syndrome, or torsades de pointes).
  7. Has a history of autoimmune disease requiring systemic immunosuppressive therapy with daily doses of prednisone >10 mg/day or equivalent doses, or any other form of immunosuppressive therapy. Hormone replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for thyroid, adrenal or pituitary insufficiency) for endocrinopathies are not considered prohibited forms of systemic treatment of an autoimmune disease.
  8. Has a history of noninfectious pneumonitis that required steroids or a history of interstitial lung disease.
  9. Has an evidence of active, non-infectious pneumonitis.
  10. Has a history of allogeneic tissue or solid organ transplant.
  11. Has an active infection requiring systemic therapy.
  12. Has a known history of human immunodeficiency virus (HIV) infection or any other relevant congenital or acquired immunodeficiency.
  13. Has a known hepatitis B virus surface antigen seropositive or detectable hepatitis C infection viral load. Note: Participants who have positive hepatitis B core antibody or hepatitis B surface antigen antibody can be enrolled but must have an undetectable hepatitis B viral load.
  14. History of any of the following ≤6 months before first dose: congestive heart failure New York Heart Association Grade III or IV, unstable angina, myocardial infarction, unstable symptomatic ischemic heart disease, uncontrolled hypertension despite appropriate medical therapy, ongoing symptomatic cardiac arrhythmias >Grade 2, pulmonary embolism or symptomatic cerebrovascular events, or any other serious cardiac condition (e.g., pericardial effusion or restrictive cardiomyopathy). Chronic atrial fibrillation on stable anticoagulant therapy is allowed.
  15. Psychiatric illness/social circumstances that would limit compliance with study requirements and substantially increase the risk of AEs or has compromised ability to provide written informed consent.
Open or close this module Contacts/Locations
Central Contact Person: Takeda Contact
Telephone: +1-877-825-3327
Email: medinfoUS@takeda.com
Study Officials: Study Director
Study Director
Takeda
Locations: United States, Arizona
HonorHealth
[Recruiting]
Scottsdale, Arizona, United States, 85258
Contact:Contact: Site Contact 480-323-1350 ssharma@honorhealth.com
Contact:Principal Investigator: Sunil Sharma
HonorHealth
Scottsdale, Arizona, United States, 85258
United States, California
University of California Irvine Medical Center
[Recruiting]
Orange, California, United States, 92868
Contact:Contact: Site Contact 714-456-7356 ktewari@uci.edu
Contact:Principal Investigator: Krishnansu Tewari
University of California Irvine Medical Center
Orange, California, United States, 92868
Stanford Cancer Institute (SCI)
[Recruiting]
Stanford, California, United States, 94305
Contact:Contact: Site Contact 650-507-5624 ctjchen@stanford.edu
Contact:Principal Investigator: Christopher Chen
Stanford Cancer Institute (SCI)
Stanford, California, United States, 94305
United States, Connecticut
Yale Cancer Center
[Recruiting]
New Haven, Connecticut, United States, 06520
Contact:Contact: Site Contact 203-785-5944 patricia.lorusso@yale.edu
Contact:Principal Investigator: Patricia LoRusso
Yale Cancer Center
New Haven, Connecticut, United States, 06520
United States, Georgia
Georgia Cancer Center at Augusta University
[Not yet recruiting]
Augusta, Georgia, United States, 30912
Contact:Contact: Site Contact 706-721-3977 sghamande@augusta.edu
Contact:Principal Investigator: Sharad Ghamande
Georgia Cancer Center at Augusta University
Augusta, Georgia, United States, 30912
United States, Maryland
The Center for Cancer and Blood Disorders - PPDS
[Recruiting]
Bethesda, Maryland, United States, 20817
Contact:Contact: Site Contact 301-571-0019 victor.priego@aoncology.com
Contact:Principal Investigator: Victor Priego
The Center for Cancer and Blood Disorders - PPDS
Bethesda, Maryland, United States, 20817
United States, New Jersey
Morristown Medical Center
[Not yet recruiting]
Morristown, New Jersey, United States, 07960
Contact:Contact: Site Contact 973-971-7111 eric.whitman@atlantichealth.org
Contact:Principal Investigator: Eric Whitman
Morristown Medical Center
Morristown, New Jersey, United States, 07960
Cancer Institute of New Jersey
[Not yet recruiting]
New Brunswick, New Jersey, United States, 08901
Contact:Contact: Site Contact 646-685-9242 sanjay.goel@rutgers.edu
Contact:Principal Investigator: Sanjay Goel
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
United States, New York
Montefiore Einstein Cancer Center - BRANY - PPDS
[Recruiting]
Bronx, New York, United States, 10461
Contact:Contact: Site Contact 857-236-8272 efeldman@montefiore.org
Contact:Principal Investigator: Eric Feldman
Montefiore Einstein Cancer Center - BRANY - PPDS
Bronx, New York, United States, 10461
United States, North Carolina
University of North Carolina at Chapel Hill
[Not yet recruiting]
Chapel Hill, North Carolina, United States, 27514
Contact:Contact: Site Contact 919-843-7713 moschos@med.unc.edu
Contact:Principal Investigator: Stergios Moschos
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27514
United States, Oklahoma
University of Oklahoma Peggy and Charles Stephenson Cancer Center
[Recruiting]
Oklahoma City, Oklahoma, United States, 73104
Contact:Contact: Site Contact 405-271-8001 Ext. 48955 susanna-ulahannan@ouhsc.edu
Contact:Principal Investigator: Susanna Ulahannan
University of Oklahoma Peggy and Charles Stephenson Cancer Center
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Providence Cancer Institute, Franz Clinic
[Recruiting]
Portland, Oregon, United States, 97213
Contact:Contact: Site Contact 503-215-5696 rachel.sanborn@providence.org
Contact:Principal Investigator: Rachel Sanborn
Providence Cancer Institute, Franz Clinic
Portland, Oregon, United States, 97213
United States, Pennsylvania
Fox Chase Cancer Center
[Recruiting]
Philadelphia, Pennsylvania, United States, 19111
Contact:Contact: Site Contact 215-214-1676 anthony.olszanski@fccc.edu
Contact:Principal Investigator: Anthony Olszanski
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
UPMC Hillman Cancer Center
[Recruiting]
Pittsburgh, Pennsylvania, United States, 15213
Contact:Contact: Site Contact 412-623-2294 najjaryg@upmc.edu
Contact:Principal Investigator: Yana Najjar
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
University of Texas Southwestern Medical Center
[Recruiting]
Dallas, Texas, United States, 75390
Contact:Contact: Site Contact 214-645-4673 jade.homsi@utsouthwestern.edu
Contact:Principal Investigator: Jade Homsi
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
START South Texas Accelerated Research Therapeutics
[Recruiting]
San Antonio, Texas, United States, 78229
Contact:Contact: Site Contact 210-593-5250 drew.rasco@startsa.com
Contact:Principal Investigator: Drew Rasco
START South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States, 78229
United States, Virginia
University of Virginia Health System
[Recruiting]
Charlottesville, Virginia, United States, 22908
Contact:Contact: Site Contact 434-297-5504 mr7db@virginia.edu
Contact:Principal Investigator: Matthew Reilley
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Virginia Cancer Specialists (Fairfax) - USOR
[Recruiting]
Fairfax, Virginia, United States, 22031
Contact:Contact: Site Contact 703-208-3108 alexander.spira@usoncology.com
Contact:Principal Investigator: Alexander Spira
Virginia Cancer Specialists (Fairfax) - USOR
Fairfax, Virginia, United States, 22031
Brazil
Cetus Hospital Dia Oncologia
[Not yet recruiting]
Belo Horizonte, Brazil, 30110-140
Contact:Contact: Site Contact +553135191686 bruno@cortes.com
Contact:Principal Investigator: Bruno Aragao
Cetus Hospital Dia Oncologia
Belo Horizonte, Brazil, 30110-140
Instituto Mederi de Pesquisa e Saude
[Not yet recruiting]
Curitiba, Brazil, 99001970
Contact:Contact: Site Contact +555435811831 felipethome.pesquisaclinica@gmail.com
Contact:Principal Investigator: Felipe Thome dos Santos
INCA Instituto Nacional de Cancer
[Recruiting]
Rio De Janeiro, Brazil, 20230-230
Contact:Contact: Site Contact +21969024255 flora.lino@gmail.com
Contact:Principal Investigator: Flora de Moraes Lino da Silva
INCA Instituto Nacional de Cancer
Rio De Janeiro, Brazil, 20230-230
Instituto D'Or de Pesquisa e Ensino
[Not yet recruiting]
Rio de Janeiro, Brazil, 20231-050
Contact:Contact: Site Contact +552132076585 cbaldotto@inca.gov.br
Contact:Principal Investigator: Clarissa Baldotto
Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira
Rio de Janeiro, Brazil, 20941-150
Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira
[Recruiting]
Rio de Janeiro, Brazil, 20941-150
Contact:Contact: Site Contact +5511994869758 camila.venchiarutti@hc.fm.usp.br
Contact:Principal Investigator: Camila Venchiarutti Moniz
Oncoclinicas Rio de Janeiro SA
[Not yet recruiting]
Rio de Janeiro, Brazil, 22250-905
Contact:Contact: Site Contact +552121270282 pedro.marchi@medicos.oncoclinicas.com
Contact:Principal Investigator: Pedro Martins de Marchi
AC Camargo Cancer Center
[Not yet recruiting]
Sao Paulo, Brazil, 01509-900
Contact:Contact: Site Contact +551121895138 thiago.oncologia@gmail.com
Contact:Principal Investigator: Thiago Oliveira
Brazil, Parana
Instituto de Oncologia Do Parana
[Recruiting]
Curitiba, Parana, Brazil, 80530-010
Contact:Contact: Site Contact +554132079788 johnny@iop.com.br
Contact:Principal Investigator: Johnny Camargo
Instituto de Oncologia Do Parana
Curitiba, Parana, Brazil, 80530-010
Brazil, Rio Grande Do Sul
ONCOSITE Centro de Pesquisa Clinica Em Oncologia
[Recruiting]
Ijui, Rio Grande Do Sul, Brazil, 98700-000
Contact:Contact: Site Contact +555533319393 oncosite.oncologia@gmail.com
Contact:Principal Investigator: Fabio Franke
ONCOSITE Centro de Pesquisa Clinica Em Oncologia
Ijui, Rio Grande Do Sul, Brazil, 98700-000
Hospital de Clinicas de Porto Alegre (HCPA) - PPDS
[Recruiting]
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
Contact:Contact: Site Contact +555133598619 sazevedo@hcpa.edu.br
Contact:Principal Investigator: Sergio de Azevedo
Hospital de Clinicas de Porto Alegre (HCPA) - PPDS
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
[Recruiting]
Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
Contact:Contact: Site Contact +555133203039 carlos.barrios@cpors.com
Contact:Principal Investigator: Carlos Barrios
Brazil, Sao Paulo
Fundacao Pio XII Hospital de Cancer de Barretos
[Recruiting]
Barretos, Sao Paulo, Brazil, 14784-370
Contact:Contact: Site Contact +558888888888 aryscampos@yahoo.com.br
Contact:Principal Investigator: Arinilda Campos Bragagnoli
Fundacao Pio XII Hospital de Cancer de Barretos
Barretos, Sao Paulo, Brazil, 14784-370
Hospital de Base Da Faculdade de Medicina de Sao Jose Do Rio Preto
[Recruiting]
Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15090-000
Contact:Contact: Site Contact +551732015054 joaodcguedes@gmail.com
Contact:Principal Investigator: Joao Daniel Cardoso Guedes
Hospital de Base Da Faculdade de Medicina de Sao Jose Do Rio Preto
Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15090-000
China, Guangdong
Sun Yat-Sen University Cancer Center
[Recruiting]
Guangzhou, Guangdong, China, 510060
Contact:Contact: Site Contact +862087343228 rhuaxu@163.com
Contact:Principal Investigator: Ruihua Xu
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China, 510060
China, Hubei
Union Hospital Tongji Medical College Huazhong University of Science and Technology
[Recruiting]
Wuhan, Hubei, China
Contact:Contact: Site Contact +8613307187507 lgl6714@163.com
Contact:Principal Investigator: Guiling Li
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
China, Zhejiang
The First Affiliated Hospital, Zhejiang University School of Medicine - PPDS
[Recruiting]
Hangzhou, Zhejiang, China, 310003
Contact:Contact: Site Contact +8615257126683 drjhping@163.com
Contact:Principal Investigator: Haiping Jiang
The First Affiliated Hospital, Zhejiang University School of Medicine - PPDS
Hangzhou, Zhejiang, China, 310003
Croatia
Clinical Hospital Centre Osijek
[Recruiting]
Osijek, Croatia, 31000
Contact:Contact: Site Contact +38531511490 dr.ivanamarkovic@gmail.com
Contact:Principal Investigator: Ivana Canjko
Clinical Hospital Centre Osijek
Osijek, Croatia, 31000
General Hospital Pula
[Not yet recruiting]
Pula, Croatia, 52100
Contact:Contact: Site Contact +38598335797 dtrivanovic@obpula.hr
Contact:Principal Investigator: Dragan Trivanovic
General Hospital Pula
Pula, Croatia, 52100
University Hospital Centre Split
[Recruiting]
Split, Croatia, 21000
Contact:Contact: Site Contact +38521556539 videpopovic@yahoo.com
Contact:Principal Investigator: Vide Popovic
University Hospital Centre Split
Split, Croatia, 21000
Croatia, Grad Zagreb
Klinicki bolnicki centar Zagreb
[Recruiting]
Zagreb, Grad Zagreb, Croatia, 10000
Contact:Contact: Site Contact +38512385317 marko.jakopovic@kbc-zagreb.hr
Contact:Principal Investigator: Marko Jakopovic
Klinicki bolnicki centar Zagreb
Zagreb, Grad Zagreb, Croatia, 10000
Japan, Tiba
National Cancer Center East
[Recruiting]
Kashiwa-Shi, Tiba, Japan, 277-0882
Contact:Contact: Site Contact +81471331111 kharano@east.ncc.go.jp
Contact:Principal Investigator: Kenichi Harano
National Cancer Center East
Kashiwa-Shi, Tiba, Japan, 277-0882
Japan, Tokyo
National Cancer Center Hospital
[Recruiting]
Chuo-Ku, Tokyo, Japan, 104-0045
Contact:Contact: Site Contact +81335475201 nbryamam@ncc.go.jp
Contact:Principal Investigator: Noboru Yamamoto
National Cancer Center Hospital
Chuo-Ku, Tokyo, Japan, 104-0045
The Cancer Institute Hospital of Japanese Foundation For Cancer Research
[Recruiting]
Chuo-Ku, Tokyo, Japan, 104-0045
Contact:Contact: Site Contact +81335422511 shigehisa.kitano@jfcr.or.jp
Contact:Principal Investigator: Shigehisa Kitano
The Cancer Institute Hospital of Japanese Foundation For Cancer Research
Chuo-Ku, Tokyo, Japan, 104-0045
Latvia
Pauls Stradins Clinical University Hospital
[Recruiting]
Riga, Latvia, LV-1002
Contact:Contact: Site Contact +37129453125 a.gerina@inbox.lv
Contact:Principal Investigator: Aija Gerina-Berzina
Pauls Stradins Clinical University Hospital
Riga, Latvia, LV-1002
Riga East Clinical University Hospital Latvian Oncology Center
[Recruiting]
Riga, Latvia, LV-1079
Contact:Contact: Site Contact +37129455458 alinta.hegmane@aslimnica.lv
Contact:Principal Investigator: Alinta Hegmane
Riga East Clinical University Hospital Latvian Oncology Center
Riga, Latvia, LV-1079
Lithuania, Kauno Apskritis
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
[Recruiting]
Kaunas, Kauno Apskritis, Lithuania, LT-50161
Contact:Contact: Site Contact +37061533001 laurakairev@yahoo.com
Contact:Principal Investigator: Laura Kairevice
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
Kaunas, Kauno Apskritis, Lithuania, LT-50161
Hospital of Lithuanian University of Health Sciences Kauno klinikos
[Recruiting]
Kaunas, Kauno Apskritis, Lithuania, LT-50161
Contact:Contact: Site Contact +37037327125 marius.zemaitis@kaunoklinikos.lt
Contact:Principal Investigator: Marius Zemaitis
Hospital of Lithuanian University of Health Sciences Kauno klinikos
Kaunas, Kauno Apskritis, Lithuania, LT-50161
Lithuania, Vilniaus Apskritis
National Cancer Institute
[Recruiting]
Vilnius, Vilniaus Apskritis, Lithuania, LT-08660
Contact:Contact: Site Contact +37052786700 edita.baltruskeviciene@nvi.lt
Contact:Principal Investigator: Edita Baltruskeviciene
National Cancer Institute
Vilnius, Vilniaus Apskritis, Lithuania, LT-08660
Poland
Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy
[Recruiting]
Bydgoszcz, Poland, 85-796
Contact:Contact: Site Contact +48501446778 bzur1@wp.pl
Contact:Principal Investigator: Bogdan Zurawski
Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy
Bydgoszcz, Poland, 85-796
Instytut Medyczny Santa Familia Sp. z o. o.
[Recruiting]
Lodz, Poland, 90-302
Contact:Contact: Site Contact +48426895477 ewakalinka@wp.pl
Contact:Principal Investigator: Ewa Kalinka
Instytut Medyczny Santa Familia Sp. z o. o.
Lodz, Poland, 90-302
Specjalistyczna Praktyka Lekarska Slawomir Mandziuk
[Recruiting]
Lublin, Poland, 20-362
Contact:Contact: Site Contact +48814402474 slawman7@wp.pl
Contact:Principal Investigator: Slawomir Mandziuk
Specjalistyczna Praktyka Lekarska Slawomir Mandziuk
Lublin, Poland, 20-362
Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie
[Recruiting]
Olsztyn, Poland, 10-357
Contact:Contact: Site Contact +48895322978 j.kolbsielecki@gmail.com
Contact:Principal Investigator: Jaroslaw Kolb-Sielecki
Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie
Olsztyn, Poland, 10-357
Med-Polonia Sp. z o.o.
[Recruiting]
Poznan, Poland, 60-569
Contact:Contact: Site Contact +48616561700 rramlau@gmail.com
Contact:Principal Investigator: Rodryg Ramlau
Med-Polonia Sp. z o.o.
Poznan, Poland, 60-569
Poland, Lodzkie
Centrum Terapii Wspolczesnej
[Not yet recruiting]
Lodz, Lodzkie, Poland, 90-242
Contact:Contact: Site Contact +48422300609 m.ulanska@ctw.com.pl
Contact:Principal Investigator: Malgorzata Ulanska
Centrum Terapii Wspolczesnej
Lodz, Lodzkie, Poland, 90-242
Poland, Pomorskie
Uniwersyteckie Centrum Kliniczne-Ul. Smoluchowskiego 17
[Recruiting]
Gdansk, Pomorskie, Poland, 80-214
Contact:Contact: Site Contact +48583492979 rafald@gumed.edu.pl
Contact:Principal Investigator: Rafal Dziadziuszko
Uniwersyteckie Centrum Kliniczne-Ul. Smoluchowskiego 17
Gdansk, Pomorskie, Poland, 80-214
Switzerland
Universitaetsspital Bern - Inselspital
[Recruiting]
Bern, Switzerland, 3010
Contact:Contact: Site Contact +41316326858 julian.wampfler@insel.ch
Contact:Principal Investigator: Julian Wampfler
Universitaetsspital Bern - Inselspital
Bern, Switzerland, 3010
Switzerland, Thurgau (de)
Kantonsspital Muensterlingen
[Recruiting]
Munsterlingen, Thurgau (de), Switzerland, 8596
Contact:Contact: Site Contact +41716862202 ioannis.metaxas@stgag.ch
Contact:Principal Investigator: Ioannis Metaxas
Kantonsspital Muensterlingen
Munsterlingen, Thurgau (de), Switzerland, 8596
Switzerland, Ticino (it)
Ente Ospedaliero Cantonale
[Not yet recruiting]
Bellinzona, Ticino (it), Switzerland, 6500
Contact:Contact: Site Contact +41918114840 patrizia.froesch@eoc.ch
Contact:Principal Investigator: Patrizia Froesch
Switzerland, Zurich (de)
Kantonsspital Winterthur
[Recruiting]
Winterthur, Zurich (de), Switzerland, 8400
Contact:Contact: Site Contact +418888888888 laetitia.mauti@ksw.ch
Contact:Principal Investigator: Laetitia Mauti
Kantonsspital Winterthur
Winterthur, Zurich (de), Switzerland, 8400
Open or close this module IPDSharing
Plan to Share IPD: Yes
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting Information:
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame:
Access Criteria:
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
URL: https://vivli.org/ourmember/takeda/
Open or close this module References
Links: Description: To obtain more information about this study, click this link.
Available IPD/Information:

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