A Study to Assess BMS-986207 in Combination With Nivolumab and Ipilimumab as First-line Treatment for Participants With Stage IV Non-Small Cell Lung Cancer
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| ClinicalTrials.gov Identifier: NCT05005273 |
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Recruitment Status :
Completed
First Posted : August 13, 2021
Results First Posted : February 28, 2024
Last Update Posted : February 28, 2024
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Non-Small Cell Lung Cancer | Drug: Nivolumab Drug: Ipilimumab Drug: BMS-986207 Other: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2 Randomized Study of BMS-986207 in Combination With Nivolumab and Ipilimumab as First-line Treatment for Participants With Stage IV Non-Small Cell Lung Cancer |
| Actual Study Start Date : | October 3, 2022 |
| Actual Primary Completion Date : | December 27, 2022 |
| Actual Study Completion Date : | December 27, 2022 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Arm A |
Drug: Nivolumab
Specified dose on specified days
Other Names:
Drug: Ipilimumab Specified dose on specified days
Other Names:
Drug: BMS-986207 Specified dose on specified days |
| Experimental: Arm B |
Drug: Nivolumab
Specified dose on specified days
Other Names:
Drug: Ipilimumab Specified dose on specified days
Other Names:
Other: Placebo Specified dose on specified days |
- Progression Free Survival by BICR [ Time Frame: From first dose to progression or death, 2.3 months ]
PFS is defined for all randomized participants as the date from randomization to the date of the documentation of disease progression by BICR or death due to any cause, whichever is earlier.
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
- Progression Free Survival by Investigator [ Time Frame: From first dose to progression or death, 2.3 months ]
PFS is defined for all randomized participants as the date from randomization to the date of the documentation of disease progression or death due to any cause, whichever is earlier.
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
- Overall Response Rate (ORR) by BICR [ Time Frame: From first dose to progression or death, 2.3 months ]
ORR is defined as the percentage of participants with a confirmed Best overall response of Complete Response (CR) or Partial Response (PR) by RECIST v1.1.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
- Overall Response Rate (ORR) by Investigator [ Time Frame: From first dose to progression or death, 2.3 months ]
ORR is defined as the percentage of participants with a confirmed Best overall response of Complete Response (CR) or Partial Response (PR) by RECIST v1.1.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
- Duration of Response (DOR) by Investigator [ Time Frame: From first dose to progression or death, 2.3 months ]
DOR is defined for participants who have a confirmed CR or PR as the date from first documented CR or PR per RECIST v1.1 to the date of the documentation of disease progression or death due to any cause, whichever is earlier.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
- Overall Survival (OS) [ Time Frame: From randomization to time of death, 2.3 months ]OS is defined as the time from randomization to the time of death due to any cause.
- Number of Participants Who Had AEs, SAEs, AEs Leading to Discontinuation and Deaths. [ Time Frame: From first dose to progression or death, 2.3 months ]
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.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically confirmed metastatic 1L Stage IV non-small cell lung cancer (NSCLC) of squamous or nonsquamous histology
- No prior systemic anti-cancer treatment given as primary therapy for advanced or metastatic NSCLC
- Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- A formalin-fixed, paraffin-embedded (FFPE) tumor tissue block or a minimum of 20 unstained slides of tumor tissue obtained during screening or prior to enrollment
- Life expectancy of at least 3 months at the time of first dose
Exclusion Criteria:
- Participants with epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or c-ros oncogene 1 (ROS-1) mutations which are sensitive to available targeted inhibitor therapy. Participants with nonsquamous histology and unknown EGFR, ALK, or ROS-1 status are also excluded
- Participants with known B-rapidly accelerated fibrosarcoma proto-oncogene (BRAF) V600E mutations that are sensitive to available targeted inhibitor therapy. Participants with unknown or indeterminate BRAF mutation status are eligible.
- Untreated central nervous system metastases
- Leptomeningeal metastases (carcinomatous meningitis)
- Concurrent malignancy requiring treatment
- Active, known, or suspected autoimmune disease
- Interstitial lung disease
- Uncontrolled or significant cardiovascular disease
Other protocol-defined inclusion/exclusion criteria apply
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): NCT05005273
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| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Documents provided by Bristol-Myers Squibb:
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT05005273 |
| Other Study ID Numbers: |
CA020-016 2021-000039-29 ( EudraCT Number ) U1111-1263-4850 ( Other Identifier: WHO ) |
| First Posted: | August 13, 2021 Key Record Dates |
| Results First Posted: | February 28, 2024 |
| Last Update Posted: | February 28, 2024 |
| Last Verified: | January 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| 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 Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) |
| Time Frame: | See Plan Description |
| Access Criteria: | See Plan Description |
| URL: | https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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