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Colorectal CancerPhase 3BATTMANNCT07152821

Botensilimab + Balstilimab vs Best Supportive Care as Therapy in Chemo-refractory, Unresectable, Colorectal Adenocarcinoma

A Phase 3 study testing Balstilimab and Botensilimab in people with Colorectal Cancer, run by Canadian Cancer Trials Group at 1 site in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study is being done to answer the main question of: Do patients with colorectal cancer that cannot be removed by surgery, that is treated with two new immunotherapy drugs, botensilimab and balstilimab, live longer? Other important questions include: Is their quality of life better? Do their tumours slow in growth… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
Balstilimab and Botensilimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteCanada
Study dates
31 Mar 2026to 13 Jul 2026
Phase
Phase 3
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

  • Must have histologically confirmed colorectal adenocarcinoma that is not deficient mismatch repair (dMMR) or microsatellite instability-high (MSI-H).
  • Received and failed all prior available therapies, such that the standard of care for the patient would be best supportive care (BSC).
  • Must have an Eastern Cooperative Oncology Group (ECOG) performance status 0, or 1.
  • Must have presence of measurable or evaluable disease as defined by Response Evaluation Criteria in Solid Tumours (RECIST 1.1).
  • A life expectancy of ≥ 12 weeks at the time of study entry.
  • Must be ≥ 18 years of age.
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  • Participants must consent to provision of, and investigator must agree to submit, a representative archival formalin fixed paraffin block of tumour tissue for correlative analyses when tumour tissue is available.
  • Participants must have adequate organ and marrow function measured within 14 days prior to randomization.
  • Participant is able (i.e. sufficiently fluent) and willing to complete the quality of life and health utility questionnaires in either English or French.
  • Participant consent must be appropriately obtained in accordance with applicable local and national regulatory requirements.
  • Participants must be accessible for treatment and follow-up. Investigators must assure themselves the participants enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.
  • In accordance with CCTG policy, protocol treatment is to begin within 2 working days of participant enrolment.
  • Participants of childbearing potential or partners of participants of childbearing potential must have agreed to use a highly effective contraceptive method

Who cannot join

  • Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen may be eligible for this trial, however, consultation with CCTG in advance of enrolment is required.
  • A history of primary immunodeficiency, solid organ transplant or allogeneic bone marrow transplant.
  • Current or prior use of immunosuppressive medication within 7 days before the first dose of study drugs, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid.
  • Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease that has required systemic treatment within 2 years of the start of study drug.
  • Active or uncontrolled intercurrent illness.
  • Active brain metastases or leptomeningeal metastases.
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  • Receipt of live attenuated vaccination administered within 30 days prior to randomization.
  • Lactating women who choose to breast feed.
  • Any active disease condition which would render the protocol treatment dangerous or impair the ability of the participant to receive protocol therapy.
  • Any condition that does not permit compliance with the protocol.
  • Receipt of anti-cancer chemotherapy or biologic therapy within the lesser of i) 21 days, or ii) the usual cycle length of the regimen prior to the first planned dose of study drug.
  • Receipt of radiotherapy or investigational agents within four weeks of first planned dose of study drug.
  • Any unresolved toxicity (≥ CTCAE grade 2) from previous anti-cancer therapy.
  • Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
  • History of partial or complete bowel obstruction within the last 3 months prior to study enrolment, signs/symptoms of bowel obstruction or known radiologic evidence of impending obstruction.
  • Refractory ascites defined as requiring 2 or more therapeutic paracenteses within the last 4 weeks or ≥ 4 times within the last 3 months or ≥ 1 time within the last 2 weeks or requiring diuretics within 2 weeks prior to study enrolment.
  • Active or ongoing diarrhea of CTCAE grade 2 or higher.
  • Tumour is mismatch repair deficient (dMMR) or microsatellite instability- high (MSI-H) per a standard local testing method.
  • Prior exposure to anti-PD-1/PD-L1/CTLA-4 therapy.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Kingston Health Science Centre

    Kingston, Ontario, K0H1H0

Other trials in Canada

About this study

Official title: Botensilimab + Balstilimab vs Best Supportive Care as Therapy in Chemo-refractory, Unresectable, Colorectal Adenocarcinoma: The BATTMAN Trial

This study is being done to answer the main question of: Do patients with colorectal cancer that cannot be removed by surgery, that is treated with two new immunotherapy drugs, botensilimab and balstilimab, live longer? Other important questions include: Is their quality of life better? Do their tumours slow in growth or possibly shrink in size? Are there markers in their tumour or blood that can predict whether they achieve any of these benefits? In addition, the study is done to confirm the safety of these immunotherapy drugs and to determine how long it takes for the body to metabolize them.

Read the detailed description

This study is being done to find out if this approach (taking botensilimab and balstilimab) is better or worse than the usual approach for colorectal adenocarcinoma that cannot be removed by surgery. The usual approach is defined as care most people get for colorectal adenocarcinoma that cannot be removed by surgery and that has become resistant to treatment with available therapies.

The usual approach for patients who are not in a study is supportive care with drugs and other treatments that may help to make them feel better or may improve their quality of life. This treatment is known as "best supportive care." Although patients with best supportive care can feel better for some months, the cancer usually continues to grow.

Being tested
Best Supportive Care, Balstilimab, Botensilimab
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Best Supportive CareOther

    Measures designed to provide palliation of symptoms and improve quality of life as much as possible

  • BalstilimabDrug

    450mg IV every 3 weeks

  • BotensilimabDrug

    75mg IV every 6 weeks x 4 doses

Study groups in NCT07152821
Study groupRoleWhat they receive
Best Supportive CareActive comparatorNot described
Receives: Other: Best Supportive Care
Botensilimab + Balstilimab and Best Supportive CareExperimentalNot described
Receives: Other: Best Supportive Care; Drug: Balstilimab; Drug: Botensilimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    Measured: 34 months

Secondary outcomes (8)

  1. Progression Free Survival (PFS) based on RECIST 1.1 criteria

    Measured: 34 months

  2. Overall Response Rate (ORR) based on RECIST 1.1 criteria

    Measured: 34 months

  3. Clinical Benefit Rate (CBR) at 6 months based on RECIST 1.1 criteria

    Measured: 34 months

  4. Health Related Quality of Life (HRQoL) utilizing EORTC QLQ-C30

    30 items measuring: 5 functional domains (physical, role, cognitive, emotional and social functioning); 3 symptom domains (fatigue, pain, and nausea/vomiting); a global health status/QoL domain; and 6 single-item measures that assesses other symptoms such as dyspnea and insomnia.

    Measured: 34 months

  5. Health Related Quality of Life (HRQoL) utilizing EORTC QLQ-CR29

    Disease specific module that supplements the core questionnaire with 18 items on gastrointestinal symptoms, such as diarrhea constipation and abdominal pain; separate items for patients with stomas; 4 items on sexual function; and 6 scales and 11 individual items to capture colorectal cancer-specific concerns.

    Measured: 34 months

  6. Social Determinants of Health (SDoH) utilizing the SDoH questionnaire

    Measured: 34 months

  7. Number and Severity of Adverse Events based on CTCAE v5.0

    Measured: 34 months

  8. Health Economics utilizing the health utility questionnaire EQ-5D-5L

    Measured: 34 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2025
  2. Study start31 Mar 2026
  3. Primary completion13 Jul 2026
  4. Study completion13 Jul 2026

Why it stopped: Pharmaceutical Sponsor discontinued trial financial support

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07152821
Sponsor's protocol ID
CO33
Acronym
BATTMAN
Status last verified
Jul 2026
First submitted
26 Aug 2025
Last updated
16 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Balstilimab and Botensilimab in people with Colorectal Cancer, run by Canadian Cancer Trials Group at 1 site in Canada.

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 13 inclusion and 19 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: stopped early, as of the sponsor's last update on 16 Jul 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 Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Pharmaceutical Sponsor discontinued trial financial support). 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?

Overall Survival (time frame: 34 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07152821.

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 16 Jul 2026.

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