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

Launched by BRISTOL-MYERS SQUIBB · Nov 15, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called BMS-986360, both on its own and in combination with traditional chemotherapy or a medication called nivolumab, for patients with advanced solid tumors. The main goal is to see how safe and tolerable this treatment is for people who have certain types of advanced cancer, including non-small cell lung cancer, metastatic triple-negative breast cancer, and others. If you're between the ages of 65 and 74 and have been diagnosed with one of these cancers, you might be eligible to participate.

If you join the trial, you'll need to provide tissue samples from your tumor, which helps researchers understand how the treatment works. Throughout the study, healthcare providers will closely monitor your health and any side effects. This trial is currently recruiting participants, and it’s important to know that only certain patients who have already tried other standard therapies and did not respond well to them can take part. This study aims to provide valuable information that could lead to better treatment options for patients with advanced cancers.

Gender

ALL

Eligibility 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.