Comparing 8 approaches for advanced malignant tumors
Official title: A Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors
A Phase 1/1b Open-label Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors
- Phase 1
- 8 groups
- Sites in Vancouver, Montreal and 1 more city
- Recruiting
Interventions (4)
- Medication
BMS-986488
Specified dose on specified days
- Medication
Adagrasib
Specified dose on specified days
- Medication
Cetuximab
Specified dose on specified days
- Medication
Nivolumab
Specified dose on specified days
Canadian Sites (3)
2 of 3 recruiting
- Recruiting
BC Cancer Vancouver
Vancouver, British Columbia
- Recruiting
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus
Québec, Quebec
- Not yet recruiting
Local Institution - 0015
Montreal, Quebec
Eligibility Criteria
See who this study is looking for16 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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.
- +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.
- +Participants must have an Eastern Cooperative Oncology Groups (ECOG) Performance Status of 0 or 1.
- +Participants must have measurable disease per RECIST v1.1.
Exclusion
- −Leptomeningeal metastasis (carcinomatous meningitis).
- −Untreated central nervous system (CNS) metastases.
- −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 protocolProtocolThe detailed plan a study must follow.Read more →-defined inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more →/exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → apply.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 1Phase 1The earliest stage of human testing, in a small group, focused on safety.Read more → — an early safety study in a small group, checking how it is tolerated and at what dose.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 8 groups in this study.
Groups A and E receive BMS-986488.
Registry label: A: Part 1A: BMS-986488 Monotherapy · E: Part 2A: BMS-986488 Monotherapy
Groups B and F receive BMS-986488 and Adagrasib.
Registry label: B: Part 1B: BMS-986488 + Adagrasib · F: Part 2B: BMS-986488 + Adagrasib
Groups C and G receive BMS-986488, Adagrasib and Cetuximab.
Registry label: C: Part 1C: BMS-986488 + Adagrasib + Cetuximab · G: Part 2C: BMS-986488 + Adagrasib + Cetuximab
Groups D and H receive BMS-986488 and Nivolumab.
Registry label: D: Part 1D: BMS-986488 + Nivolumab · H: Part 2D: BMS-986488 + Nivolumab
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Groups are assigned by the study team using set rules, rather than by chance.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 437 people.
The study is currently expected to finish around October 2027.
The main measurement is taken over: Until the end of the Safety Follow-up periodFollow-upContinued check-ins after the treatment part is finished.Read more → (up to approximately 100 days after last dose).
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Number of participants with Adverse EventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → (AEs) — measured over Until the end of the Safety Follow-up periodFollow-upContinued check-ins after the treatment part is finished.Read more → (up to approximately 100 days after last dose).
Number of participants with Serious AEs (SAEs) — measured over Until the end of the Safety Follow-up period (up to approximately 100 days after last dose).
Number of participants with AEs meeting protocolProtocolThe detailed plan a study must follow.Read more →-defined Dose-Limiting Toxicity (DLT) criteria — measured over From first dose of study treatment until end of cycle 1 (1 Cycle = 28 Days).
Number of participants with AEs leading to discontinuation — measured over Until the end of the Safety Follow-up period (up to approximately 100 days after last dose).
The study lists 1 further main measurements.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06764771 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About BMS-986488Drug
Specified dose on specified days
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About AdagrasibDrug
Specified dose on specified days
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About CetuximabDrug
Specified dose on specified days
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About NivolumabDrug
Specified dose on specified days
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Groups are assigned by the study team using set rules, rather than by chance.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Until the end of the Safety Follow-up periodFollow-upContinued check-ins after the treatment part is finished.Read more → (up to approximately 100 days after last dose).
The study as a whole is currently expected to finish around 2027-10-15.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 437 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 3 locations, including: Vancouver, British Columbia, Canada; Montreal, Quebec, Canada; Québec, Quebec, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.