A Study of BMS-986360/CC-90001 Alone and in Combination With Chemotherapy or Nivolumab in Advanced Solid Tumors
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| ClinicalTrials.gov Identifier: NCT05625412 |
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Recruitment Status :
Recruiting
First Posted : November 22, 2022
Last Update Posted : May 15, 2023
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Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
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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 |
| 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:
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| 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 :
- Number of participants with Adverse Events (AEs) [ Time Frame: Up to approximately 2 years ]
- Number of participants with Serious Adverse Events (SAEs) [ Time Frame: Up to approximately 2 years ]
- Number of participants with Dose-Limiting Toxicities (DLTs) [ Time Frame: Up to approximately 2 years ]
- Number of participants with AEs leading to discontinuation [ Time Frame: Up to approximately 2 years ]
- Number of deaths [ Time Frame: Up to approximately 2 years ]
Secondary Outcome Measures :
- Maximum observed plasma concentration (Cmax) [ Time Frame: Up to approximately 2 years ]
- Time of maximum observed plasma concentration (Tmax) [ Time Frame: Up to approximately 2 years ]
- Area under the plasma concentration-time curve (AUC) [ Time Frame: Up to approximately 2 years ]
- 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 ]
- Part 2: ORR based on RECIST v1.1 by blinded independent central review (BICR) assessment [ Time Frame: Up to approximately 2 years ]
- Part 1: Duration of Response (DOR) based on RECIST v1.1 by investigator [ Time Frame: Up to approximately 2 years ]
- Part 2: DOR based on RECIST v1.1 by BICR assessment [ Time Frame: Up to approximately 2 years ]
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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
| 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
Show 40 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
| 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: | May 15, 2023 |
| Last Verified: | May 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 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Bristol-Myers Squibb:
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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 |