Microsatellite-stable Colorectal CancerPhase 2NCT07011550
Phase 2, Single-arm Trial of BMS-986340 in Association With Nivolumab, Trifluridine/Tipiracil and Bevacizumab for Patients Refractory to Standard of Care Treatment and With Microsatellite-stable Colorectal Cancer
A Phase 2 study testing Nivolumab, Bevacizumab and BMS-986340 in people with Microsatellite-stable Colorectal Cancer and Standard of Care, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To learn if the drug combination of BMS-986340, nivolumab, trifluridine/tipiracil, and bevacizumab can help to control advanced or metastatic MSS-CRC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Microsatellite-stable Colorectal Cancer, Standard of Care, Nivolumab
- What is being tested?
- Nivolumab, Bevacizumab and BMS-986340
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2025to 1 Jul 2030
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Prior treatment with trifluridine/tipiracil, regorafenib, or fruquitinib.
- Prior treatment with anti-programmed cell death-1 (anti-PD-1), anti-programmed cell death ligand (anti-PD-L1), anti-programmed cell death ligand 2, anti-CD137, anti-OX-40, anti CD40, anti-cytotoxic T lymphocyte associated antigen-4 antibodies, or any other immune checkpoint inhibitors
- Prior organ or tissue allograft.
- Presence or history of immunodeficiency that requires chronic use of systemic corticosteroids (≥ 10mg of prednisone equivalent per day) or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment
- Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
- Major surgery within the past 4 weeks (the surgical incision should be fully healed before study drug administration).
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- Any anticancer therapy within the past 2 weeks before enrollment.
- Extended field radiation within the past 4 weeks or limited field radiation within the past 2 weeks before enrollment.
- Participant s who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > Grade 1) with the exception of alopecia and platinuminduced peripheral neuropathy.
- Participants who are receiving any other investigational agents.
- History of intestinal disease or major gastric surgery likely to alter absorption of study treatment (to be determined by the treating physician)
- Active brain metastases, unless adequately treated and participant is neurologically stable (except for residual symptoms of central nervous system treatment) for at least 2 weeks prior to enrollment without corticosteroids or are on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent)
- Participants with symptomatic leptomeningeal disease
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to BMS-986340, nivolumab, or any other immune checkpoint inhibitors, TAS- 102, bevacizumab or any of its ingredients, including polysorbate 80-containing infusion.
- Has hereditary problems of galactose intolerance, total lactase deficiency or glucosegalactose malabsorption
- In the investigator's opinion, uncontrolled diabetes mellitus even under treatment.
- In the investigator's opinion, uncontrolled or clinically significant cardiovascular disease defined as New York Heart Association (NYHA) classification III or IV, arterial hypertension or uncontrolled or symptomatic arrhythmia
- Deep vein thrombosis within 4 weeks prior to randomization
- Deep arterial thromboembolic events including cerebrovascular accident or myocardial infarction within the last 6 months prior to enrollment.
- Severe/unstable angina, symptomatic congestive heart failure New York Heart Association (NYHA) class III or IV
- Participants with uncontrolled intercurrent illness (Indicate clearly what type or extent)
- Participants with psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study because BMS-986340] is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with BMS-986340, breastfeeding should be discontinued if the mother is treated with BMS-986340. These potential risks may also apply to other agents used in this study.
Trial locations and contacts
1 site in 1 country.
About this study
To learn if the drug combination of BMS-986340, nivolumab, trifluridine/tipiracil, and bevacizumab can help to control advanced or metastatic MSS-CRC.
Read the detailed description
Primary Objectives
- To determine the safety of the combination of BMS-986340, nivolumab, trifluridine/tipiracil and bevacizumab.
- To determine the objective response rate (ORR) of the BMS-986340, nivolumab, trifluridine/tipiracil and bevacizumab
Secondary Objectives
- To determine the progression-free survival (PFS), overall survival (OS) and duration of response (DOR) in participants with advanced or metastatic MSS-CRC.
- Being tested
- Nivolumab, Bevacizumab, BMS-986340, Trifluridine + Tipiracil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
Given by IV
BevacizumabDrug
Given by IV
BMS-986340Drug
Given by IV
Trifluridine + TipiracilDrug
Given by PO
| Study group | Role | What they receive |
|---|---|---|
| SLI/Exp | Experimental | SLI/Exp: Treatment with BMS-986340 + Nivolumab + Trifluridine/tipiracil + Bevacizumab Q4W Receives: Drug: Nivolumab; Drug: Bevacizumab; Drug: BMS-986340; Drug: Trifluridine + Tipiracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and adverse events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2025
- Study start15 Aug 2025
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2030 (estimated)
Why it stopped: PI Request
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microsatellite-stable Colorectal CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Strategic Alliance
- Responsible party
- Sponsor
- Investigators
- Madhulika Eluri, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07011550
- Sponsor's protocol ID
- 2025-0342
- Other IDs
- NCI-2025-04161
- Status last verified
- Oct 2026
- First submitted
- 5 Jun 2025
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2, Single-arm Trial of BMS-986340 in Association With Nivolumab, Trifluridine/Tipiracil and Bevacizumab for Patients Refractory to Standard of Care Treatment and With Microsatellite-stable Colorectal Cancer
- ClinicalTrials.gov ID
- NCT07011550
- Acronym / sponsor ID
- 2025-0342
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: PI Request
- Enrolment
- 7 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Strategic Alliance
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2030 (estimated)
- First posted
- 9 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To learn if the drug combination of BMS-986340, nivolumab, trifluridine/tipiracil, and bevacizumab can help to control advanced or metastatic MSS-CRC.
Detailed description
Primary Objectives
- To determine the safety of the combination of BMS-986340, nivolumab, trifluridine/tipiracil and bevacizumab.
- To determine the objective response rate (ORR) of the BMS-986340, nivolumab, trifluridine/tipiracil and bevacizumab
Secondary Objectives
- To determine the progression-free survival (PFS), overall survival (OS) and duration of response (DOR) in participants with advanced or metastatic MSS-CRC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SLI/Exp | Experimental | Drug: Nivolumab, Drug: Bevacizumab, Drug: BMS-986340, Drug: Trifluridine + TipiracilSLI/Exp: Treatment with BMS-986340 + Nivolumab + Trifluridine/tipiracil + Bevacizumab Q4W |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (23 listed)
- Prior treatment with trifluridine/tipiracil, regorafenib, or fruquitinib.
- Prior treatment with anti-programmed cell death-1 (anti-PD-1), anti-programmed cell death ligand (anti-PD-L1), anti-programmed cell death ligand 2, anti-CD137, anti-OX-40, anti CD40, anti-cytotoxic T lymphocyte associated antigen-4 antibodies, or any other immune checkpoint inhibitors
- Prior organ or tissue allograft.
- Presence or history of immunodeficiency that requires chronic use of systemic corticosteroids (≥ 10mg of prednisone equivalent per day) or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment
- Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NivolumabGiven by IV | Drug | SLI/Exp |
| BevacizumabGiven by IV | Drug | SLI/Exp |
| BMS-986340Given by IV | Drug | SLI/Exp |
| Trifluridine + TipiracilGiven by PO | Drug | SLI/Exp |
Primary outcome
Safety and adverse events (AEs)
Time frame: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Madhulika Eluri, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab, Bevacizumab and BMS-986340 in people with Microsatellite-stable Colorectal Cancer and Standard of Care, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and adverse events (AEs) (time frame: Through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.