Comparing 9 approaches for cervical cancer
Official title: A Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors
A Phase 1/2 Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors
- Phase 1
- 9 groups
- Sites in Ottawa, Edmonton and 4 more cities
- Recruiting
Interventions (4)
- Medication
BMS-986340
Specified dose on specified days
- Medication
BMS-936558-01
Specified dose on specified days
- Medication
Docetaxel
Specified dose on specified days
- Medication
Pumitamig
Specified dose on specified days
Canadian Sites (6)
3 of 6 recruiting
- Recruiting
Cross Cancer Institute
Edmonton, Alberta
- Recruiting
Hamilton Health Sciences-Juravinski Cancer Centre
Hamilton, Ontario
- Recruiting
Centre Hospitalier de luniversite de Montreal
Montreal, Quebec
- Completed
Local Institution - 0030
Vancouver, British Columbia
- Completed
Local Institution - 0009
Toronto, Ontario
- Completed
Local Institution - 0016
Ottawa
Eligibility Criteria
See who this study is looking for31 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Untreated CNS metastases.
- +Leptomeningeal metastases.
- +Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarkerBiomarkerSomething measurable in the body used as a signal of what is happening.Read more → analysis.
- +Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and at least 1 lesion accessible for biopsy. Fine needle biopsy, cytology, and bone lesion biopsies are not acceptable.
- +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, (except for Part 1C, 2C and 2D, where participants with prior docetaxel use for the advanced/metastatic setting will be excluded), including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated.
- +Advanced or metastatic disease and have received, be refractory to, not be a candidate for, or be intolerant of existing therapies known to provide clinical benefit for the condition of the participant.
- +Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →
- +Primary central nervous system (CNS) malignancy.
- +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.
- +History of or with active interstitial lung disease or pulmonary fibrosis.
- +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 criteria apply.
- +Women who are pregnant or breastfeeding.
- +Major surgery within 4 weeks of study drug administration.
Exclusion
- −Untreated CNS metastases.
- −Leptomeningeal metastases.
- −Primary central nervous system (CNS) malignancy.
- −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.
- −History of or with active interstitial lung disease or pulmonary fibrosis.
- −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.
- −Women who are pregnant or breastfeeding.
- −Major surgery within 4 weeks of study drug administration.
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 →/2 — a combined study that starts with early safety and continues into what the treatment does.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 9 groups in this study.
Groups A, B and F receive BMS-986340.
Registry label: A: Part 1A: BMS-986340 Dose Escalation · B: Part 2A: BMS-986340 Dose Expansion · F: Part 1A-J: BMS-986340 Dose Escalation
Groups C, D and G receive BMS-986340, together with one or more of: BMS-936558-01.
Registry label: C: Part 1B: BMS-986340 + Nivolumab Dose Escalation · D: Part 2B: BMS-986340 + Nivolumab Dose Expansion · G: Part 1B-J: BMS-986340 + Nivolumab Dose Escalation
Groups E and H receive BMS-986340 and Docetaxel.
Registry label: E: Part 1C: BMS-986340 + Docetaxel Dose Escalation · H: Part 2C: BMS-986340 + Docetaxel Dose Expansion
Group I receives BMS-986340 and Pumitamig.
Registry label: I: Part 2D: BMS-986340 + Pumitamig Dose Expansion
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
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 1,109 people.
The study is currently expected to finish around August 2031.
The main measurement is taken over: Up to 120 weeks.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Incidence of adverse eventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → (AEs) — measured over Up to 120 weeks.
Incidence of serious adverse eventsSerious adverse eventAn adverse event meeting a formal severity threshold, such as requiring hospital admission.Read more → (SAEs) — measured over Up to 120 weeks.
Incidence of AEs meeting protocolProtocolThe detailed plan a study must follow.Read more → defined dose-limiting toxicity (DLT) criteria — measured over Up to either 21 or 28 days.
Incidence of AEs leading to discontinuation — measured over Up to 120 weeks.
The study lists 1 further main measurements.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT04895709 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-986340Drug
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 BMS-936558-01Drug
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 DocetaxelDrug
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 PumitamigDrug
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.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
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: Up to 120 weeks.
The study as a whole is currently expected to finish around 2031-08-31.
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 1,109 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 7 locations, including: Ottawa, Canada; Edmonton, Alberta, Canada; Vancouver, British Columbia, Canada; Hamilton, Ontario, Canada; Toronto, Ontario, Canada; Montreal, Quebec, Canada, and 1 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
The purpose of this study is to assess the safety, tolerability, and recommended dose(s) of BMS-986340 as monotherapy and in combination with nivolumab, docetaxel, or Pumitamig in participants with advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in participants with advanced solid tumors.
Other Sites (2)
Local Institution - 0006
New York, New York, United States
Local Institution - 0002
New York, New York, United States
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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.