ClinicalTrials.gg
RecruitingNCT07227636Updated Sep 22, 2026

A Study of Botensilimab and Balstilimab for Colorectal Cancer With ctDNA+ After Surgery and Chemotherapy

A Phase 2 interventional study of Botensilimab and Balstilimab in Colorectal Cancer and Rectal Cancer, sponsored by Memorial Sloan Kettering Cancer Center. Recruiting at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.

Primary conditionRectal NeoplasmsRegistry: Colorectal NeoplasmsReclassifiedWhy we changed it
Registry
Colorectal Neoplasms — the first condition term the registry derived for this study.
ClinicalTrials.gg
Rectal Neoplasms
Why
  1. The study's listed conditions name Rectal Neoplasms, a narrower term within Colorectal Neoplasms.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Memorial Sloan Kettering Cancer Center · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Nov 2025; still recruiting 1 year later.

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Phase
Phase 2
Study type
Interventional
Enrollment
284
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 54 studies in Rectal Neoplasms by Memorial Sloan Kettering Cancer Center — 6 open to participants now, 10 under way, none of them phase 3. Rectal Neoplasms · Memorial Sloan Kettering Cancer Center.

Planned enrollment
4th of 34
284 · median 38
Started
2025
the only one that year
Phase 2
19 of 54
4 open now
Registered
53rd of 54
by date

Among the 54 studies in Rectal Neoplasms by Memorial Sloan Kettering Cancer Center, this one is the 4th largest by planned enrollment of the 34 interventional ones that give a count, is the only one that started in 2025, is one of 19 in phase 2, and was the 53rd registered.

Rectal Neoplasms

2,402 studies on the registry are indexed under Rectal Neoplasms; 589 are open to participants now.

Browse Rectal Neoplasms studies →

Open to participants now

6 of the 54 studies in Rectal Neoplasms by Memorial Sloan Kettering Cancer Center are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 6 open studies →

Where they have run

Who these studies take

Of the 405 Rectal Neoplasms studies recruiting now, 210 (52%) set no upper age limit and 143 (35%) stop at 75 or younger; 19 take children under 18; 16 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 54 studies in Rectal Neoplasms by Memorial Sloan Kettering Cancer Center, or all of them as a file.
02

Study 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) 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.

03

Conditions studied

  • Colorectal Cancer
  • Rectal Cancer

Browse trials for

Keywords

  • Persistent Circulating Tumor DNA
  • Botensilimab
  • Balstilimab
  • ctDNA
  • ctDNA+
  • immunotherapy
  • checkpoint inhibitor
  • dual checkpoint blockade
  • AGEN1181
  • AGEN2034
  • CTLA-4 inhibitor
  • PD-1 inhibitor
04

In context

Rectal Neoplasms Reclassified

2,402 studies on the registry are indexed under Rectal Neoplasms; 589 are open to participants now.

This study's planned enrollment of 284 is above the median of 65 across 1,753 interventional studies indexed under Rectal Neoplasms.

Browse Rectal Neoplasms studies →

Lead sponsor

Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,964 studies on the registry; 326 are open to participants now.

Of its 135 completed or terminated interventional studies of FDA-regulated products, 71 (53%) have results posted.

Compared within Rectal Neoplasms, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Colorectal Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subject or legally authorized representative, is willing and able to provide written .
  • - or cytologically- confirmed colorectal cancer.
  • ≥ 18 years of age on day of signing informed consent.
  • Consent for use of and blood draws for research purposes.
  • Performance status of 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.
  • Consent to undergo MSK IMPACT or NGS, if not previously done
  • Disease specific criteria:

    1. Cohorts 1a and 2a: Undergone a complete surgical resection (R0) for stage III colon or rectal cancer, followed by 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.
    2. Cohorts 1b and 2b: Undergone a complete surgical resection (R0) for liver (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:

  1. ≥ 1,500/mm3.
  2. count ≥ 75,000/mm3.
  3. ≥ 9.0 g/dL
  4. (CrCl) ≥60 mL/min.
  5. and ALT ≤ 2.5 ×
  6. ≤ 1.5 × ULN or Direct bilirubin ≤ ULN

    • Subjects of (or with partners of childbearing potential) must use effective 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).

Exclusion criteria

Exclusion Criteria:

  • Presence of 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 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 therapy or any other form of therapy within 7 days prior to the first dose of trial treatment.

    1. 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.
    2. The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed.
  • to botensilimab or balstilimab or any of its .
  • 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

    a. 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-L1, or anti-CTLA-4 agent.
  • Active 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:

    1. Subjects with vitiligo or alopecia
    2. 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 (HIV). Patients on stable highly active antiretroviral therapy with undetectable viral load and normal 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 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 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 within 30 days of planned start of study therapy
Terms in these criteria, in plain language(27)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

CD4 count

The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

06

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
284 participants (estimated)

Study arms

  • Experimental
    Cohort 1a: Stage III MSS Colorectal Cancer (Botensilimab and Balstilimab)

    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.

    Drug: Botensilimab · Drug: Balstilimab

  • Experimental
    Cohort 1b: MSS CRLM (Botensilimab and Balstilimab)

    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.

    Drug: Botensilimab · Drug: Balstilimab

  • Experimental
    Cohort 2a: Stage 3 MSS Colorectal Cancer (Botensilimab and Balstilimab vs. Placebo) Randomized

    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

    Drug: Botensilimab · Drug: Balstilimab · Other: Placebo

  • Experimental
    Cohort 2b: MSS CRLM (Botensilimab and Balstilimab vs. Placebo) Randomized

    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

    Drug: Botensilimab · Drug: Balstilimab · Other: Placebo

Interventions

  • All patients will receive botensilimab IV on day 1 of the 42 day cycle for 4 doses

    Also known as: AGEN1181

  • 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.

    Also known as: AGEN2034

  • OtherPlacebo

    Placebo

07

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months

  2. 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.

    Time frame: 6 months

  3. Recurrence-free survival (RFS) (Cohort 2a)

    Time frame: 1 year

  4. Recurrence-free survival (RFS) (Cohort 2b)

    Time frame: 1 year

08

Study locations

7 of 7 sites recruiting
  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
    Basking Ridge, New Jersey 07920, United States
    Recruiting
    • Neil Segal, MD, PhD · Contact646-888-4187
  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
    Middletown, New Jersey 07748, United States
    Recruiting
    • Neil Segal, MD, PhD · Contact646-888-4187
  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)
    Montvale, New Jersey 07645, United States
    Recruiting
    • Neil Segal, MD, PhD · Contact646-888-4187
  • Memorial Sloan Kettering Commack (Limited Protocol Activities)
    Commack, New York 11725, United States
    Recruiting
    • Neil Segal, MD, PhD · Contact646-888-4187
  • Memorial Sloan Kettering Westchester (All Protocol Activities)
    Harrison, New York 10604, United States
    Recruiting
    • Neil Segal, MD, PhD · Contact646-888-4187
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
    New York, New York 10065, United States
    Recruiting
    • Neil Segal, MD,PhD · Contact646-888-4187
    • Luis Diaz, MD · Contact646-888-4641
    • Neil Segal, MD, PhD · Principal investigator
  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)
    Rockville Centre, New York 11553, United States
    Recruiting
    • Neil Segal, MD, PhD · Contact646-888-4187
09

References and documents

Individual participant data

Plan to share: 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.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2025 (actual). Primary completion is estimated for Nov 2030, 60 months after the start.

Of 227 non-industry phase 2 interventional studies under Rectal Neoplasms, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 80. This study's planned 60 months is above that.

Counting every sponsor, half of 241 studies reached it within 46 months; a quarter within 31 and three quarters within 75.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 10, 2025
First posted
Nov 13, 2025
StartActual
Nov 7, 2025
Primary completionEst.
Nov 2030
CompletionEst.
Nov 2030
Last update
Sep 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT07227636
Collaborators
Agenus Inc.
Responsible party
Sponsor
First posted
Nov 13, 2025
Start date
Nov 7, 2025
Primary completion
Nov 2030 (estimated)
Completion
Nov 2030 (estimated)
Last update
Sep 22, 2026

Study contacts

Neil Segal, MD, PhD
Contact
crc@mskcc.org
646-888-4187
Luis Diaz, MD
Contact
646-888-4641
Neil Segal, MD, PhD
principal investigator · Memorial Sloan Kettering Cancer Center

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Botensilimab · Balstilimab

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