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A Phase 1/2 Study of BMS-986340 with and without Nivolumab or Docetaxel in Solid Tumors
EU CTIS ID: 2023-503651-10-00
What this study is testing
To assess the safety, tolerability, and to determine the MTD, MAD, and/or RP2D(s) of BMS-986340 administered as monotherapy and in combination with nivolumab or docetaxel
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker analysis
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and at least 1 lesion accessible for biopsy
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Radiographically documented progressive disease on or after the most recent therapy
- Received standard-of-care therapies, including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated (except for Part 1C, where participants with prior docetaxel use for the advanced/metastatic setting will be excluded)
- Participants must have advanced or metastatic disease, and have received, be refractory to, not be a candidate for, or be intolerant to existing therapies known to provide clinical benefit for the condition of the participant. Eligible tumor types for each Part are listed below: - Parts 1A and 1B: NSCLC, SCCHN, MSS-CRC, gastric/GEJ adenocarcinoma, cervical cancer (SCC or adenocarcinoma), RCC, UC, PDAC, melanoma, OC, or TNBC. - Parts 2A and 2B: NSCLC, SCCHN, gastric/GEJ adenocarcinoma, or up to 3 additional tumor types from Parts 1A and 1B may be considered based on emerging data. - Part 1C: NSCLC, SCCHN, gastric/GEJ adenocarcinoma, OC, or TNBC. Other protocol-defined inclusion criteria apply.
You likely can't join if
- Women who are pregnant or breastfeeding
- Major surgery within 4 weeks of study drug administration
- History of or with active interstitial lung disease or pulmonary fibrosis Other protocol-defined exclusion criteria apply
- Primary central nervous system (CNS) malignancy
- Untreated CNS metastases
- Leptomeningeal metastases
See the full eligibility criteria
- Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker analysis
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and at least 1 lesion accessible for biopsy
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Radiographically documented progressive disease on or after the most recent therapy
- Received standard-of-care therapies, including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated (except for Part 1C, where participants with prior docetaxel use for the advanced/metastatic setting will be excluded)
- Participants must have advanced or metastatic disease, and have received, be refractory to, not be a candidate for, or be intolerant to existing therapies known to provide clinical benefit for the condition of the participant. Eligible tumor types for each Part are listed below: - Parts 1A and 1B: NSCLC, SCCHN, MSS-CRC, gastric/GEJ adenocarcinoma, cervical cancer (SCC or adenocarcinoma), RCC, UC, PDAC, melanoma, OC, or TNBC. - Parts 2A and 2B: NSCLC, SCCHN, gastric/GEJ adenocarcinoma, or up to 3 additional tumor types from Parts 1A and 1B may be considered based on emerging data. - Part 1C: NSCLC, SCCHN, gastric/GEJ adenocarcinoma, OC, or TNBC. Other protocol-defined inclusion criteria apply.
- Women who are pregnant or breastfeeding
- Major surgery within 4 weeks of study drug administration
- History of or with active interstitial lung disease or pulmonary fibrosis Other protocol-defined exclusion criteria apply
- Primary central nervous system (CNS) malignancy
- Untreated CNS metastases
- Leptomeningeal metastases
- Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment
- Active, known, or suspected autoimmune disease
- Condition requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment
- Prior organ or tissue allograft
- Uncontrolled or significant cardiovascular disease
The study team makes the final eligibility decision.
Where it's taking place
- Israel
- Australia
- Japan
- United States
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Israel; Australia; Japan; United States; Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.