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Trial record 1 of 1 for:    BMS-986360/CC-90001
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A Study of BMS-986360/CC-90001 Alone and in Combination With Chemotherapy or Nivolumab in Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05625412
Recruitment Status : Recruiting
First Posted : November 22, 2022
Last Update Posted : December 20, 2023
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The aim of this study is to assess the safety and tolerability of BMS-986360 as monotherapy and in combination with chemotherapy or nivolumab in participants with advanced solid tumors.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: BMS-986360 Drug: Docetaxel Drug: Nivolumab Drug: Capecitabine Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-label, Multicenter Study of BMS-986360/CC-90001 Alone and in Combination With Chemotherapy or Nivolumab in Advanced Solid Tumors
Actual Study Start Date : December 9, 2022
Estimated Primary Completion Date : May 1, 2026
Estimated Study Completion Date : July 30, 2027

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: BMS-986360 Drug: BMS-986360
Specified dose on specified days
Other Name: CC-90001

Experimental: BMS-986360 + Docetaxel Drug: BMS-986360
Specified dose on specified days
Other Name: CC-90001

Drug: Docetaxel
Specified dose on specified days
Other Name: Taxotere®

Experimental: BMS-986360 + Nivolumab Drug: BMS-986360
Specified dose on specified days
Other Name: CC-90001

Drug: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo®
  • BMS-936558

Experimental: BMS-986360 + Capecitabine Drug: BMS-986360
Specified dose on specified days
Other Name: CC-90001

Drug: Capecitabine
Specified dose on specified days
Other Name: Xeloda®




Primary Outcome Measures :
  1. Number of participants with Adverse Events (AEs) [ Time Frame: Up to approximately 2 years ]
  2. Number of participants with Serious Adverse Events (SAEs) [ Time Frame: Up to approximately 2 years ]
  3. Number of participants with Dose-Limiting Toxicities (DLTs) [ Time Frame: Up to approximately 2 years ]
  4. Number of participants with AEs leading to discontinuation [ Time Frame: Up to approximately 2 years ]
  5. Number of deaths [ Time Frame: Up to approximately 2 years ]

Secondary Outcome Measures :
  1. Maximum observed plasma concentration (Cmax) [ Time Frame: Up to approximately 2 years ]
  2. Time of maximum observed plasma concentration (Tmax) [ Time Frame: Up to approximately 2 years ]
  3. Area under the plasma concentration-time curve (AUC) [ Time Frame: Up to approximately 2 years ]
  4. Part 1: Objective response rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST v1.1) by investigator [ Time Frame: Up to approximately 2 years ]
  5. Part 2: ORR based on RECIST v1.1 by blinded independent central review (BICR) assessment [ Time Frame: Up to approximately 2 years ]
  6. Part 1: Duration of Response (DOR) based on RECIST v1.1 by investigator [ Time Frame: Up to approximately 2 years ]
  7. Part 2: DOR based on RECIST v1.1 by BICR assessment [ Time Frame: Up to approximately 2 years ]


Information from the National Library of Medicine

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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants in Part 1 must have histologic or cytologic confirmation of non-small cell lung cancer (NSCLC), metastatic triple negative breast cancer (mTNBC), squamous cell carcinoma of head and neck (SCCHN), pancreatic adenocarcinoma (PAAD), renal cell carcinoma (RCC), microsatellite-stable colorectal carcinoma (MSS CRC), or sarcoma, that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease per RECIST v1.1. In Part 2, only participants with histologic confirmation of advanced NSCLC or mTNBC with measurable disease per RECIST v1.1 are eligible.
  • In Part 2, archival biopsy collected within 3 months of screening with no intervening therapy (formalin-fixed, paraffin embedded [FFPE] blocks or a minimum of 20 freshly cut unstained FFPE slides with an associated pathological report) or fresh biopsy collection at Screening and fresh biopsy collection at cycle 3 day 1 (C3D1) (± 5 days) are mandatory, while it is strongly encouraged but optional at progression. Therefore, the participant in Part 2 must have a suitable tumor lesion for the biopsy procedure, as judged by the investigator, in order to be eligible for the study.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • Participants resistant/refractory to or intolerant of existing standard therapies known to provide clinical benefit (in addition, participants with NSCLC must be resistant or refractory to anti-PD-(L)1-based immunotherapy)

Exclusion Criteria:

  • Participants with primary central nervous system (CNS) disease, or tumors with CNS metastases as the only disease site, will be excluded. Participants with controlled brain metastases, however, will be allowed to enroll. Controlled brain metastases are defined as no radiographic progression for at least 4 weeks following radiation and/or surgical treatment (or 4 weeks of observation if no intervention is clinically indicated), no longer taking steroids for at least 2 weeks prior to first dose of study intervention, and with no new or progressive neurological signs and symptoms.
  • Participants with a condition requiring systemic treatment with corticosteroids (> 10 mg daily prednisone equivalent) within 14 days or other immunosuppressive medications within 30 days of randomization. Inhaled or topical steroids and adrenal replacement steroid doses > 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease.
  • Participants with concurrent malignancy or history of prior malignancy active within 2 years (except history of early-stage basal/squamous cell skin cancer or non-invasive or in situ cancers who have undergone definitive treatment) are excluded unless treatment was completed at least 2 years before randomization and the participant has no evidence of disease.
  • Participants with NSCLC with known or not tested for epidermal growth factor receptor (EGFR) or V-raf murine sarcoma viral oncogene homolog B1 (BRAF) V600E mutations, or anaplastic lymphoma kinase (ALK) or receptor tyrosine kinase (ROS1) translocations sensitive to available targeted inhibitor therapy

Other protocol-defined inclusion/exclusion criteria apply.


Information from the National Library of Medicine

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): NCT05625412


Contacts
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Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com
Contact: First line of the email MUST contain the NCT# and Site #.

Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT05625412    
Other Study ID Numbers: IM043-004
2022-500930-27 ( EudraCT Number )
First Posted: November 22, 2022    Key Record Dates
Last Update Posted: December 20, 2023
Last Verified: December 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bristol-Myers Squibb:
Solid tumors
Nivolumab
Chemotherapy
BMS-986360
CC-90001
Additional relevant MeSH terms:
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Neoplasms
Docetaxel
Capecitabine
Nivolumab
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antineoplastic Agents, Immunological
Immune Checkpoint Inhibitors