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This purpose of this study is to determine if experimental treatment with BMS-986488, alone, or in combinations is safe, tolerable, and has anti-cancer activity in patients with advanced malignant tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1A: BMS-986488 Monotherapy | Experimental |
| |
| Part 1B: BMS-986488 + Adagrasib | Experimental |
| |
| Part 1C: BMS-986488 + Adagrasib + Cetuximab | Experimental |
| |
| Part 1D: BMS-986488 + Nivolumab | Experimental |
| |
| Part 2A: BMS-986488 Monotherapy | Experimental |
| |
| Part 2B: BMS-986488 + Adagrasib | Experimental |
| |
| Part 2C: BMS-986488 + Adagrasib + Cetuximab | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986488 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Adverse Events (AEs) | Until the end of the Safety Follow-up period (up to approximately 100 days after last dose) | |
| Number of participants with Serious AEs (SAEs) | Until the end of the Safety Follow-up period (up to approximately 100 days after last dose) | |
| Number of participants with AEs meeting protocol-defined Dose-Limiting Toxicity (DLT) criteria | From first dose of study treatment until end of cycle 1 (1 Cycle = 28 Days) | |
| Number of participants with AEs leading to discontinuation | Until the end of the Safety Follow-up period (up to approximately 100 days after last dose) | |
| Number of deaths | From time of informed consent up to 52 weeks after end of treatment visit |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Until Cycle 4, Day 1 (1 Cycle = 28 Days) | |
| Time of maximum observed concentration (Tmax) | Until Cycle 4, Day 1 (1 Cycle = 28 Days) | |
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Inclusion Criteria:
Participant must be ≥ 18 years of age.
Histologically confirmed diagnosis of a locally advanced and unresectable or metastatic solid tumor malignancy with any of the following tumor types:.
Part 1A: clear-cell renal cell carcinoma (ccRCC), clear-cell ovarian cancer (ccOC), non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and pancreatic ductal adenocarcinoma (PDAC).
Parts 2A, 1D, 2D: ccRCC.
i) Part 1B: solid tumors with KRAS G12C mutation.
ii) Part 2B: NSCLC with KRAS G12C mutation.
iii) Parts 1C, 2C: colorectal cancer (CRC) with KRAS G12C mutation.
Exclusion Criteria:
Untreated central nervous system (CNS) metastases.
Leptomeningeal metastasis (carcinomatous meningitis).
Impaired cardiac function or clinically significant cardiac disease.
For Parts 1B, 1C, 2B, 2C only (combination with adagrasib):.
i) History of pneumonitis or interstitial lung disease (ILD).
ii) History of prior severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).
- Other protocol-defined inclusion/exclusion criteria apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BMS Clinical Trials Contact Center www.BMSClinicalTrials.com | Contact | 855-907-3286 | Clinical.Trials@bms.com | |
| First line of the email MUST contain NCT # and Site #. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John Theurer Cancer Center at Hackensack University Medical Center | Recruiting | Hackensack | New Jersey | 07601 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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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.html
See Plan Description
See Plan Description
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| Part 2D: BMS-986488 + Nivolumab | Experimental |
|
| Adagrasib | Drug | Specified dose on specified days |
|
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| Cetuximab | Drug | Specified dose on specified days |
|
|
| Nivolumab | Drug | Specified dose on specified days |
|
|
| Area under the concentration-time curve in 1 dosing interval (AUC(TAU)) |
| Until Cycle 4, Day 1 (1 Cycle = 28 Days) |
| Objective response rate (ORR) | Defined as the proportion of participants who achieve a best overall response (BOR) of complete response (CR) or partial response (PR) assessed by the investigator using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) | From time of informed consent up to 52 weeks after end of treatment visit |
| Disease control rate (DCR) | Defined as the proportion of participants who achieve a best response of CR, PR, or stable disease (SD) assessed by the investigator using RECIST v1.1 | From time of informed consent up to 52 weeks after end of treatment visit |
| Duration of response (DOR) | Defined as the time between the date of first documented response (CR or PR) to the date of the first documented disease progression as assessed by the investigator using RECIST v1.1 or death due to any cause, whichever occurs first | From time of informed consent up to 52 weeks after end of treatment visit |
| Local Institution - 0020 | Active, not recruiting | Allentown | Pennsylvania | 18103 | United States |
| The West Clinic, PLLC dba West Cancer Center | Recruiting | Germantown | Tennessee | 38138 | United States |
|
| Local Institution - 0025 | Withdrawn | Dallas | Texas | 75390 | United States |
| Local Institution - 0031 | Active, not recruiting | Brisbane | Queensland | 4029 | Australia |
| Local Institution - 0032 | Active, not recruiting | Vancouver | British Columbia | V5Z 4E6 | Canada |
| Local Institution - 0015 | Not yet recruiting | Montreal | Quebec | H2X 0A9 | Canada |
|
| Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus | Recruiting | Québec | Quebec | G1J 1Z4 | Canada |
|
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D002292 | Carcinoma, Renal Cell |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000718190 | adagrasib |
| D000068818 | Cetuximab |
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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