Colorectal CancerPhase 2NCT07227636
A Study of Botensilimab and Balstilimab for Colorectal Cancer With ctDNA+ After Surgery and Chemotherapy
A Phase 2 study testing Botensilimab and Balstilimab in people with Colorectal Cancer and Rectal Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
The researchers are doing this study to find out whether the combination of botensilimab and balstilimab (BOT/BAL), followed by balstilimab alone, is an effective treatment for people with microsatellite stable (MSS) colorectal cancer or colorectal liver metastases (CRLM) who have measurable residual disease (MRD)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Rectal Cancer
- What is being tested?
- Botensilimab and Balstilimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 284 participants
- Where
- 7 sitesUnited States
- Study dates
- 7 Nov 2025to Nov 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Subject or legally authorized representative, is willing and able to provide written informed consent.
- Histologically- or cytologically- confirmed colorectal cancer.
- ≥ 18 years of age on day of signing informed consent.
- Consent for use of archival tissue and blood draws for research purposes.
- Performance status of ECOG 0 or 1.
- Known non-MSI-H/pMMR by IHC, PCR or NGS testing. MSKCC confirmation of non-MSI-H/pMMR status is not mandatory prior to enrollment and treatment on the study. For patients with outside testing, if sufficient tissue is available testing may be repeated at MSKCC and will not impact initial eligibility.
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- Consent to undergo MSK IMPACT or NGS, if not previously done
- Disease specific criteria:
- Cohorts 1a and 2a: Undergone a complete surgical resection (R0) for stage III colon or rectal cancer, followed by adjuvant chemotherapy with FOLFOX or CAPEOX. Post-operative chemotherapy not required if received previous oxaliplatin-based therapy. Total Neoadjuvant Therapy for rectal cancer with complete clinical and radiographic response is allowed.
- Cohorts 1b and 2b: Undergone a complete surgical resection (R0) for liver metastasis (ablation or stereotactic body radiation therapy [SBRT], but not Y-90, is permitted) and completed standard peri-operative chemotherapy. Peri-operative chemotherapy not required if received previous oxaliplatin-based therapy. Prior floxuridine via Hepatic Arterial Infusion Pump is permitted. Completed definitive treatment for the primary tumor including (R0) resection, or Total Neoadjuvant Therapy for rectal cancer with complete clinical and radiographic response.
- Positive ctDNA following completion of appropriate standard of care therapy.
- Patients must sign informed consent within 6 weeks of positive ctDNA result. The 6 weeks is considered from the date that the ctDNA is resulted, and not the date it is drawn.
- Adequate organ function, defined as:
- Absolute Neutrophil Count ≥ 1,500/mm3.
- Platelet count ≥ 75,000/mm3.
- Hemoglobin ≥ 9.0 g/dL
- Creatinine clearance (CrCl) ≥60 mL/min.
- AST and ALT ≤ 2.5 × ULN
- Bilirubin ≤ 1.5 × ULN or Direct bilirubin ≤ ULN
- Subjects of childbearing potential (or with partners of childbearing potential) must use effective contraception for the course of the study starting with the screening visit through at least 5 months after the last dose of study treatment. Appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives, or double barrier method (diaphragm plus condom).
Who cannot join
- Presence of metastatic or recurrent disease.
- Known DNA polymerase epsilon (POLE) or DNA polymerase delta (POLD) activating mutation.
- R1 (microscopic residual tumor) or R2 resection (macroscopic residual tumor at resection margin).
- Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
- Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
- Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., dexamethasone containing antiemetic regimen or steroids as CT scan contrast premedication) may be enrolled.
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- The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed.
- Hypersensitivity to botensilimab or balstilimab or any of its excipients.
- Chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent
- Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
- History of, or any evidence of active, non-infectious pneumonitis.
- Active infection requiring systemic therapy.
- Current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 90 days after the last dose of trial treatment.
- Prior therapy with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 agent.
- Active autoimmune disease or history of autoimmune disease that required systemic treatment within 2 years of the start of study treatment (i.e., with use of disease-modifying agents or immunosuppressive drugs). The following are exceptions:
- Subjects with vitiligo or alopecia
- Subjects with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement or psoriasis not requiring systemic treatment
- Known active TB (Bacillus tuberculosis).
- Uncontrolled infection with human immunodeficiency virus (HIV). Patients on stable highly active antiretroviral therapy with undetectable viral load and normal CD4 counts for at least 6 months prior to study entry are eligible. Serological testing for HIV at screening is not required
- Known to be positive for hepatitis B virus (HBV) surface antigen, or any other positive test for HBV indicating acute or chronic infection. Patients who are receiving or who have received anti-HBV therapy and have undetectable HBV DNA prior to study entry are eligible. Serological testing for HBV at screening is not required.
- Known active hepatitis C virus (HCV) as determined by positive serology and confirmed by polymerase chain reaction (PCR). Patients on or who have received antiretroviral therapy are eligible provided they are virus-free by PCR for at least 6 months prior to study entry. Serological testing for HCV at screening is not required.
- Received a live vaccine within 30 days of planned start of study therapy
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Luis Diaz, MD contact
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Neil Segal, MD, PhD, 646-888-4187
- Recruiting
Memorial Sloan Kettering Commack (Limited Protocol Activities)
Commack, New York, 11725
Neil Segal, MD, PhD, 646-888-4187
- Recruiting
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, 10604
Neil Segal, MD, PhD, 646-888-4187
- Recruiting
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
Neil Segal, MD, PhD, 646-888-4187
- Recruiting
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Neil Segal, MD, PhD, 646-888-4187
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Neil Segal, MD,PhD, 646-888-4187
Luis Diaz, MD, 646-888-4641
- Recruiting
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Rockville Centre, New York, 11553
Neil Segal, MD, PhD, 646-888-4187
About this study
Official title: Phase II Study of Adjuvant Botensilimab in Combination With Balstilimab in Patients With Colorectal Cancer and Persistent Circulating Tumor DNA Following Surgery and Chemotherapy
The researchers are doing this study to find out whether the combination of botensilimab and balstilimab (BOT/BAL), followed by balstilimab alone, is an effective treatment for people with microsatellite stable (MSS) colorectal cancer or colorectal liver metastases (CRLM) who have measurable residual disease (MRD) after standard treatment with surgery and chemotherapy or total neoadjuvant therapy (TNT).
Read the detailed description
This is a 2-part, 2-cohort each. Part-1 will be a non-randomized study of 54 subjects to assess ctDNA clearance, including 2 cohorts. Cohort 1a includes 27 patients with stage III non-MSI-H/pMMR colorectal cancer following surgery and adjuvant chemotherapy or total neoadjuvant therapy (TNT), with persistent MRD. Cohort 1b includes 27 patients with non-MSI-H/pMMR CRLM following surgery and peri-operative chemotherapy, with persistent MRD.
Part-2 will be a randomized, placebo-controlled, double-blind study of 230 patients with non- MSI-H/pMMR CRC with MRD, to assess RFS. Cohort 2a includes 113 patients with stage III non-MSI-H/pMMR colorectal cancer following surgery and adjuvant chemotherapy or TNT with persistent MRD, randomized 2:1 to treatment versus placebo.
- Conditions
- Colorectal Cancer, Rectal Cancer
- Being tested
- Botensilimab, Balstilimab, Placebo
- Keywords
- Persistent Circulating Tumor DNA, Botensilimab, Balstilimab, ctDNA, ctDNA+, immunotherapy, checkpoint inhibitor, dual checkpoint blockade, AGEN1181, AGEN2034, CTLA-4 inhibitor, PD-1 inhibitor
- Medical subject headings
- Colorectal Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BotensilimabDrug
Also called AGEN1181
All patients will receive botensilimab IV on day 1 of the 42 day cycle for 4 doses
BalstilimabDrug
Also called AGEN2034
All patients will receive balstilimab IV on days 1, 15, and 29 of the 42 day cyclePatient then continues balstilimab alone for an additional two cycles IV on days 1, 15, and 29 of the 42 day cycle.
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1a: Stage III MSS Colorectal Cancer (Botensilimab and Balstilimab) | Experimental | All patients will receive botensilimab IV on day 1 of the 42 day cycle for 4 doses, balstilimab IV on days 1, 15, and 29 of the 42 day cycle. Patient then continues balstilimab alone for an additional two cycles IV on days 1, 15, and 29 of the 42 day cycle. Receives: Drug: Botensilimab; Drug: Balstilimab |
| Cohort 1b: MSS CRLM (Botensilimab and Balstilimab) | Experimental | All patients will receive botensilimab IV on day 1 of the 42 day cycle for 4 doses, balstilimab IV on days 1, 15, and 29 of the 42 day cycle. Patient then continues balstilimab alone for an additional two cycles IV on days 1, 15, and 29 of the 42 day cycle. Receives: Drug: Botensilimab; Drug: Balstilimab |
| Cohort 2a: Stage 3 MSS Colorectal Cancer (Botensilimab and Balstilimab vs. Placebo) Randomized | Experimental | All patients will receive botensilimab IV on day 1 of the 42 day cycle for 4 doses, balstilimab IV on days 1, 15, and 29 of the 42 day cycle. Patient then continues balstilimab alone for an additional two cycles IV on days 1, 15, and 29 of the 42 day cycle OR Placebo Receives: Drug: Botensilimab; Drug: Balstilimab; Other: Placebo |
| Cohort 2b: MSS CRLM (Botensilimab and Balstilimab vs. Placebo) Randomized | Experimental | All patients will receive botensilimab IV on day 1 of the 42 day cycle for 4 doses, balstilimab IV on days 1, 15, and 29 of the 42 day cycle. Patient then continues balstilimab alone for an additional two cycles IV on days 1, 15, and 29 of the 42 day cycle OR Placebo Receives: Drug: Botensilimab; Drug: Balstilimab; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of ctDNA clearance (Cohort 1a)
The 6 months ctDNA clearance will be estimated using the binomial distribution along with exact 95% confidence intervals separately in each cohort.
Measured: 6 months
Rate of ctDNA clearance (Cohort 1b)
The 6 months ctDNA clearance will be estimated using the binomial distribution along with exact 95% confidence intervals separately in each cohort.
Measured: 6 months
Recurrence-free survival (RFS) (Cohort 2a)
Measured: 1 year
Recurrence-free survival (RFS) (Cohort 2b)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2025
- Study start7 Nov 2025
- Primary completionNov 2030 (estimated)
- Study completionNov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a 2-part, 2-cohort each, phase II study. Part 2 is randomized.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 284 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Agenus Inc.
- Responsible party
- Sponsor
- Investigators
- Neil Segal, MD, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07227636
- Sponsor's protocol ID
- 25-132
- Status last verified
- Sep 2026
- First submitted
- 10 Nov 2025
- Last updated
- 22 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Adjuvant Botensilimab in Combination With Balstilimab in Patients With Colorectal Cancer and Persistent Circulating Tumor DNA Following Surgery and Chemotherapy
- ClinicalTrials.gov ID
- NCT07227636
- Acronym / sponsor ID
- 25-132
- Conditions
- Colorectal Cancer, Rectal Cancer
- Keywords
- Persistent Circulating Tumor DNA, Botensilimab, Balstilimab, ctDNA, ctDNA+, immunotherapy, checkpoint inhibitor, dual checkpoint blockade
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 284 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Agenus Inc.
- Study start
- 7 Nov 2025 (actual)
- Primary completion
- Nov 2030 (estimated)
- Study completion
- Nov 2030 (estimated)
- First posted
- 13 Nov 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.
The researchers are doing this study to find out whether the combination of botensilimab and balstilimab (BOT/BAL), followed by balstilimab alone, is an effective treatment for people with microsatellite stable (MSS) colorectal cancer or colorectal liver metastases (CRLM) who have measurable residual disease (MRD) after standard treatment with surgery and chemotherapy or total neoadjuvant therapy (TNT).
Detailed description
This is a 2-part, 2-cohort each. Part-1 will be a non-randomized study of 54 subjects to assess ctDNA clearance, including 2 cohorts. Cohort 1a includes 27 patients with stage III non-MSI-H/pMMR colorectal cancer following surgery and adjuvant chemotherapy or total neoadjuvant therapy (TNT), with persistent MRD. Cohort 1b includes 27 patients with non-MSI-H/pMMR CRLM following surgery and peri-operative chemotherapy, with persistent MRD.
Part-2 will be a randomized, placebo-controlled, double-blind study of 230 patients with non- MSI-H/pMMR CRC with MRD, to assess RFS. Cohort 2a includes 113 patients with stage III non-MSI-H/pMMR colorectal cancer following surgery and adjuvant chemotherapy or TNT with persistent MRD, randomized 2:1 to treatment versus placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- This is a 2-part, 2-cohort each, phase II study. Part 2 is randomized.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1a: Stage III MSS Colorectal Cancer (Botensilimab and Balstilimab) | Experimental | Drug: Botensilimab, Drug: BalstilimabAll patients will receive botensilimab IV on day 1 of the 42 day cycle for 4 doses, balstilimab IV on days 1, 15, and 29 of the 42 day cycle. Patient then continues balstilimab alone for an additional two cycles IV on days 1, 15, and 29 of the 42 day cycle. |
| Cohort 1b: MSS CRLM (Botensilimab and Balstilimab) | Experimental | Drug: Botensilimab, Drug: BalstilimabAll patients will receive botensilimab IV on day 1 of the 42 day cycle for 4 doses, balstilimab IV on days 1, 15, and 29 of the 42 day cycle. Patient then continues balstilimab alone for an additional two cycles IV on days 1, 15, and 29 of the 42 day cycle. |
| Cohort 2a: Stage 3 MSS Colorectal Cancer (Botensilimab and Balstilimab vs. Placebo) Randomized | Experimental | Drug: Botensilimab, Drug: Balstilimab, Other: PlaceboAll patients will receive botensilimab IV on day 1 of the 42 day cycle for 4 doses, balstilimab IV on days 1, 15, and 29 of the 42 day cycle. Patient then continues balstilimab alone for an additional two cycles IV on days 1, 15, and 29 of the 42 day cycle OR Placebo |
| Cohort 2b: MSS CRLM (Botensilimab and Balstilimab vs. Placebo) Randomized | Experimental | Drug: Botensilimab, Drug: Balstilimab, Other: PlaceboAll patients will receive botensilimab IV on day 1 of the 42 day cycle for 4 doses, balstilimab IV on days 1, 15, and 29 of the 42 day cycle. Patient then continues balstilimab alone for an additional two cycles IV on days 1, 15, and 29 of the 42 day cycle OR Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Subject or legally authorized representative, is willing and able to provide written informed consent.
- Histologically- or cytologically- confirmed colorectal cancer.
- ≥ 18 years of age on day of signing informed consent.
- Consent for use of archival tissue and blood draws for research purposes.
- Performance status of ECOG 0 or 1.
Key exclusion criteria (24 listed)
- Presence of metastatic or recurrent disease.
- Known DNA polymerase epsilon (POLE) or DNA polymerase delta (POLD) activating mutation.
- R1 (microscopic residual tumor) or R2 resection (macroscopic residual tumor at resection margin).
- Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
- Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial 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 |
|---|---|---|
| BotensilimabAlso: AGEN1181All patients will receive botensilimab IV on day 1 of the 42 day cycle for 4 doses | Drug | Cohort 1a: Stage III MSS Colorectal Cancer (Botensilimab and Balstilimab), Cohort 1b: MSS CRLM (Botensilimab and Balstilimab), Cohort 2a: Stage 3 MSS Colorectal Cancer (Botensilimab and Balstilimab vs. Placebo) Randomized, Cohort 2b: MSS CRLM (Botensilimab and Balstilimab vs. Placebo) Randomized |
| BalstilimabAlso: AGEN2034All patients will receive balstilimab IV on days 1, 15, and 29 of the 42 day cyclePatient then continues balstilimab alone for an additional two cycles IV on days 1, 15, and 29 of the 42 day cycle. | Drug | Cohort 1a: Stage III MSS Colorectal Cancer (Botensilimab and Balstilimab), Cohort 1b: MSS CRLM (Botensilimab and Balstilimab), Cohort 2a: Stage 3 MSS Colorectal Cancer (Botensilimab and Balstilimab vs. Placebo) Randomized, Cohort 2b: MSS CRLM (Botensilimab and Balstilimab vs. Placebo) Randomized |
| PlaceboPlacebo | Other | Cohort 2a: Stage 3 MSS Colorectal Cancer (Botensilimab and Balstilimab vs. Placebo) Randomized, Cohort 2b: MSS CRLM (Botensilimab and Balstilimab vs. Placebo) Randomized |
Primary outcome
Rate of ctDNA clearance (Cohort 1a)
Time frame: 6 months
The 6 months ctDNA clearance will be estimated using the binomial distribution along with exact 95% confidence intervals separately in each cohort.
Rate of ctDNA clearance (Cohort 1b)
Time frame: 6 months
The 6 months ctDNA clearance will be estimated using the binomial distribution along with exact 95% confidence intervals separately in each cohort.
Recurrence-free survival (RFS) (Cohort 2a)
Time frame: 1 year
Recurrence-free survival (RFS) (Cohort 2b)
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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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.
Luis Diaz, MD contact
Neil Segal, MD, PhD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Botensilimab and Balstilimab in people with Colorectal Cancer and Rectal Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites 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 20 inclusion and 24 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: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Neil Segal, MD, PhD (646-888-4187, crc@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of ctDNA clearance (Cohort 1a) (time frame: 6 months). The study lists 4 primary outcomes in all. 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 22 Sep 2026.