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Safety Study of Anti-LAG-3 With and Without Anti-PD-1 in the Treatment of Solid Tumors
EU CTIS ID: 2023-508067-70-00
What this study is testing
Part A+B+A1:to assess safety,tolerability,DLTs,MTD of BMS986016 alone &in combo with nivo (advanced solid tumors); to gather preliminary efficacy information of BMS986016 alone Part C:to further establish safety & tolerability of BMS986016 + nivo administered sequentially; to investigate the preliminary efficacy of BMS986016 in combo with nivo as measured by ORR, DCR,DOR (multiple tumor types) Part D: to assess safety & tolerability of more convenient dosing regimen;Part D1-Q2W: to demonstrate preliminary clinical evidence of the treatment effect,measured by ORR,as determined by BICR using RECIST v1.1 (advanced melanoma);Part D1-Q4W: to confirm with Q4W dosing of BMS986016 160 mg in combo with nivo480 mg,the safety&efficacy of the Q2W dosing of BMS986016 80 mg in combo with nivo 240mg (advanced melanoma) Part E: to demonstrate that 480 mg BMS986016 +480 mg nivo Q4W provides significantly greater clin benefit (increased ORR) vs 160mg BMS 986016+480 mg nivoQ4W dose (melanoma)
- Phase I and Phase II (Integrated)- Other
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
- For Dose escalation: subjects with cervical, ovarian, bladder and CRC, head and neck, gastric and hepatocellular cancer naive to immunooncology agents; 1st line melanoma and 1st line/2nd line NSCLC; Renal Cell Carcinoma naive to IO; NSCLC progressing while on or after therapy with anti-PD1/anti-PDL-1 and melanoma subjects progressed while-on or after treatment with anti-PD1 or anti-PDL1 with or without anti-CTLA-4.
- For Dose Expansion: all of the above in escalation except for cervical, ovarian and CRC
- Progressed, or been intolerant to, at least one standard treatment regimen, except for subjects in 1st line cohorts.
- ECOG performance status of 0 to 2
- At least 1 lesion with measurable disease at baseline
- Availability of an existing tumor biopsy sample (and consent to allow pre-treatment tumor biopsy)
You likely can't join if
- Primary CNS tumors or solid tumors with CNS metastases as the only site of active disease
- Autoimmune disease
- Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent
- Uncontrolled CNS metastases
The study team makes the final eligibility decision.
Where it's taking place
- Japan
- United States
- Canada
- Switzerland
- Australia
- United Kingdom
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, 18-64 years, 65+ years, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Japan; United States; Canada; Switzerland; Australia; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
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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.