A Clinical Study of Intratumoral MVR-T3011 (T3011) Given as a Single Agent and in Combination With Intravenous Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors
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ClinicalTrials.gov Identifier: NCT04370587 |
Recruitment Status :
Recruiting
First Posted : May 1, 2020
Last Update Posted : August 29, 2023
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Condition or disease | Intervention/treatment | Phase |
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Solid Tumor Melanoma HNSCC Sarcoma Squamous Cell Carcinoma NSCLC | Biological: T3011 Combination Product: T3011 + pembrolizumab | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 64 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1/2a, Open-Label, Dose Escalation and Expansion Study of the Safety and Tolerability of T3011 Administered Via Intratumoral Injection as a Single Agent and in Combination With Intravenous Pembrolizumab in Patients With Advanced or Metastatic Solid Tumors |
Actual Study Start Date : | September 17, 2020 |
Estimated Primary Completion Date : | October 31, 2023 |
Estimated Study Completion Date : | October 31, 2025 |
Arm | Intervention/treatment |
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Experimental: Phase 1
T3011 single agent dose escalation in participants with solid tumors
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Biological: T3011
T3011 will be administered up to 4mL as an intratumoral injection given Q2W. |
Experimental: Phase 2a Part 1 Arm A
RP2D T3011 single agent in participants with melanoma
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Biological: T3011
T3011 will be administered up to 4mL as an intratumoral injection given Q2W. |
Experimental: Phase 2a Part 1 Arm B
RP2D T3011 single agent in participants with other solid tumors
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Biological: T3011
T3011 will be administered up to 4mL as an intratumoral injection given Q2W. |
Experimental: Phase 2a Part 2 Arm C
RP2D T3011 + pembrolizumab in participants with NSCLC
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Combination Product: T3011 + pembrolizumab
T3011 will be administered up to 4mL as an intratumoral injection in combination with intravenous pembrolizumab given Q3W. |
Experimental: Rollover Arm
RP2D T3011 + pembrolizumab in participants who have progressed on T3011 single agent
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Combination Product: T3011 + pembrolizumab
T3011 will be administered up to 4mL as an intratumoral injection in combination with intravenous pembrolizumab given Q3W. |
- Safety and tolerability of escalating doses T3011 [ Time Frame: Up to 2 years from first dose of T3011 ]Number of participants in dose escalating cohorts with dose limiting toxicities (DLTs), treatment-emergent adverse events (TEAEs), and/or changes in clinical laboratory abnormalities.
- To determine the dose(s) of T3011 to be examined in Phase 2a [ Time Frame: Through the first two T3011 injections (approximately 28 days) ]Incidence of DLTs
- Safety and tolerability of T3011 dose(s) selected from Phase 1 in disease specific cohorts [ Time Frame: Up to 2 years from first dose of T3011 ]Number of participants with treatment-emergent adverse events (TEAEs), and/or changes in clinical laboratory abnormalities.
- Characterize the safety and tolerability of T3011 in combination with pembrolizumab [ Time Frame: Up to 2 years from first dose of T3011 ]Number of participants with treatment-emergent adverse events (TEAEs), and/or changes in clinical laboratory abnormalities.
- Characterize the safety and tolerability of T3011 in combination with pembrolizumab in participants who progress on T3011 alone [ Time Frame: Up to 2 years from first dose of T3011 ]Number of participants with treatment-emergent adverse events (TEAEs), and/or changes in clinical laboratory abnormalities.
- Overall response rate (ORR) [ Time Frame: Up to 2 years from first dose of T3011 ]ORR is defined as the proportion of participants who have a partial response (PR) or complete response (CR) to intervention, based on assessments by RECIST v1.1 and iRECIST.
- Disease control rate (DCR) [ Time Frame: Up to 2 years from first dose of T3011 ]DCR is defined as the percentage of participants who have achieved CR, PR, or stable disease (SD) based on assessments by RECIST v1.1 and iRECIST.
- Duration of response (DOR) [ Time Frame: Up to 2 years from first dose of T3011 ]DOR is defined as the time from the first met CR or PR until disease progression or death due to any cause, whichever occurs first.
- Durable response (DR) [ Time Frame: Up to 2 years from first dose of T3011 ]DR is defined as objective response (CR or PR) according to RECIST v1.1 and iRECIST.
- Progression-free survival (PFS) [ Time Frame: Up to 2 years from first dose of T3011 ]PFS is defined as the time from enrollment to the first documentation of progressive disease (PD) or death from any cause, whichever occurs first per RECIST v1.1 and iRECIST.
- Overall Survival (OS) [ Time Frame: Up to 1 year after last dose of T3011 ]OS is defined as the time from enrollment to death from any cause.
- Presence of neutralizing antibodies of anti-PD-1 antibody for antidrug antibodies (ADAs) development [ Time Frame: Up to 2 years from first dose of T3011 ]To evaluate the immunogenicity of anti-PD-1 antibody expressed by T3011 given as single agent and in combination with pembrolizumab post injection.
- Presence and frequency of T3011 in injection site swab, saliva, and urine [ Time Frame: Up to 2 years from first dose of T3011 ]To evaluate the virus shedding of T3011 following intratumoral injection
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
- Age 18 years or older.
- Disease progression after standard of care (SOC) therapy or in the opinion of
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The Investigator unlikely to benefit from SOC therapy. Inclusion Diagnosis Phase 1 - Histologically or pathologically confirmed locally recurrent or metastatic advanced malignancy.
Phase 2a Part 1 i. Arm A - locally recurrent or metastatic melanoma. Participants must have received no more than 3 prior regimens for advanced or metastatic disease.
ii. Arm B - locally recurrent or metastatic HNSCC. It must also meet the following criteria: 1) Disease progression to platinum-containing chemotherapy; 2) Failure to anti-PD-1/PDL1 blockade after receiving at least 2 doses alone or in combination.
iii. Arm C - Sarcoma. Participants must have received no more than three lines of prior anti-cancer therapies.
iv. Arm D - locally recurrent or metastatic cSCC. Participants must have received no more than 3 prior regimens for advanced or metastatic disease.
Phase 2a Part 2 i.v. Arm E - Histologically or pathologically confirmed NSCLC that is advanced or recurrent, without EGFR mutation or ALK rearrangement. Participants must have received at least one line but no more than three lines of prior anti-cancer therapies.
- Measurable disease per RECIST version 1.1.
- Must have at least 1 tumor lesion that is accessible for IT injection of T3011 in the opinion of the investigator.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Life expectancy > 12 weeks.
- Demonstrate adequate organ function as defined by acceptable laboratory testing results.
- Women of child-bearing potential (WCBP) and men must agree to use adequate contraception prior to study entry, while on study treatment, and for six months after receiving last dose of T3011. WCBP must have a negative serum pregnancy test prior to W1D1.
- Last dose of previous anticancer therapy ≥ 21 days, radiotherapy > 21 days, or surgical intervention > 21 days prior to the first dose of T3011.
- Recovered from all prior anticancer therapy toxicities.
- Willingness to provide fresh tumor biopsy specimens as specified in the Schedule of Assessments.
- Capable of understanding and complying with protocol requirements.
- Signed and dated institutional review board/independent ethics committee-approved informed consent form before any protocol-directed screening procedures are performed.
Key Exclusion Criteria:
- Have only uninjectable tumors..
- Patients with injectable tumors impinging upon major airways or blood vessels.
- HNSCC only: Prior re-irradiation field containing carotid artery.
- Greater than 3 distant metastatic lymph node regions and/or metastatic lesions or the largest distant metastases with a diameter of more than 3 cm (non-sarcoma)/5 cm (sarcoma) unless the lesion is to be injected.
- Prior treatment with another OV (including T-VEC), tumor vaccines, cellular therapy or gene therapy.
- Prior intolerance to anti-PD-(L)1 monoclonal antibody or history of immunotherapy related non-infectious pneumonitis/interstitial lung disease.
- Prior treatment with anti-PD-(L)1 monoclonal antibody in combination with IL-12.
- Requires continued concurrent therapy with any drug active against HSV.
- Live vaccines, attenuated vaccines within 4 weeks prior to initiation of study treatment (participants vaccinated with inactivated vaccines can be enrolled.
- Primary or acquired immunodeficient states.
- Pregnant or lactating.
- Prior organ transplantation.
- Active hepatitis B virus, hepatitis C virus, and HIV infection or a positive serological test at Screening within 14 days of dosing with T3011.
- Active autoimmune disease or medical conditions requiring chronic steroid or immunosuppressive therapy within 4 weeks prior to first administration of study treatment.
- History of or current central nervous system metastases.
- History of seizure disorders within 6 months of Screening.
- Active oral or skin herpes lesion at Screening.
- Active interstitial lung disease (ILD)/pneumonitis or a history of ILD/pneumonitis requiring treatment with systemic steroids.
- Congestive heart failure, active coronary artery disease, unevaluated new onset angina within 3 months or unstable angina, or clinically significant cardiac arrhythmias.
- History of allergic reactions attributed to compounds of similar biological composition to HSV-1, IL-12, or anti-PD-1 monoclonal antibody.
18. Active infection with SARS-CoV-2 virus. 21. Participants with moderate to large amount of pleural effusion, ascites or pericardial effusion who need drug or medical intervention.
22. Other systemic conditions or organ abnormalities that, in the opinion of the investigator, may interfere with the conduct and/or interpretation of the current study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04370587
Contact: ImmVira Pharma Co. LTD | 781-718-5121 | clinicaltrials@immviragroup.com |
United States, Arizona | |
Banner MD Anderson Cancer Center | Recruiting |
Gilbert, Arizona, United States, 85234 | |
Contact: Jiaxin Niu, MD, PhD clinicaltrials@immviragroup.com | |
Principal Investigator: Jiaxin Niu, MD, PhD | |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Howard Kaufman, MD clinicaltrials@immviragroup.com | |
Principal Investigator: Howard Kaufman, MD | |
Dana Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02215 | |
Contact: Elizabeth Buchbinder, MD clinicaltrials@immviragroup.com | |
Principal Investigator: Elizabeth Buchbinder, MD | |
United States, Pennsylvania | |
University of Pittsburgh Medical Center | Recruiting |
Pittsburgh, Pennsylvania, United States, 15232 | |
Contact: John Kirkwood, MD clinicaltrials@immviragroup.com | |
Principal Investigator: John Kirkwood, MD | |
United States, Texas | |
Mary Crowley Cancer Research | Recruiting |
Dallas, Texas, United States, 75230 | |
Contact: Minal Barve, MD clinicaltrials@immviragroup.com | |
Principal Investigator: Minal Barve, MD | |
United States, Virginia | |
Virginia Cancer Specialists | Recruiting |
Fairfax, Virginia, United States, 22031 | |
Contact: Alexander Spira, MD clinicaltrials@immviragroup.com | |
Australia | |
Southern Oncology | Recruiting |
Bedford Park, Australia | |
Contact: Ganessan Kichenadasse clinicaltrials@immviragroup.com | |
Principal Investigator: Ganessan Kichenadasse | |
Peninsula & South Eastern Haematology and Oncology Group | Recruiting |
Frankston, Australia | |
Contact: Vinod Ganju clinicaltrials@immviragroup.com | |
Principal Investigator: Vinod Ganju | |
The Alfred | Recruiting |
Melbourne, Australia | |
Contact: Andrew Haydon clinicaltrials@immviragroup.com | |
Principal Investigator: Andrew Haydon |
Responsible Party: | ImmVira Pharma Co. Ltd |
ClinicalTrials.gov Identifier: | NCT04370587 |
Other Study ID Numbers: |
CTIV1708 |
First Posted: | May 1, 2020 Key Record Dates |
Last Update Posted: | August 29, 2023 |
Last Verified: | August 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Neoplasms Melanoma Carcinoma, Squamous Cell Sarcoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nevi and Melanomas Skin Neoplasms |
Neoplasms by Site Skin Diseases Carcinoma Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Neoplasms, Connective and Soft Tissue Pembrolizumab Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action |