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Desperate cancer patients get early access to promising drug combo

NCT ID NCT06751524

Disease control Sponsor: Agenus Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access This study
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This program offers early access to a combination of two immunotherapy drugs, botensilimab and balstilimab, for people with serious or life-threatening cancers like colorectal, pancreatic, lung, liver, melanoma, sarcoma, ovarian, or prostate cancer. It is for patients who have tried standard treatments and have no other good options. A doctor must decide if the potential benefit outweighs the risks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Botensilimab and balstilimab (combination immunotherapy drugs given by IV infusion)
What this could lead to
If it works, this could provide a treatment option for people with advanced cancers who have run out of standard therapies.
What could go wrong
This is an expanded access program, not a formal trial, so evidence is limited. The drugs are still investigational and may not work for everyone; side effects from immunotherapy can be serious.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * The patient's disease is serious or life-threatening. * The patient has undergone appropriate standard treatments; there are no comparable or satisfactory alternative treatments for the disease or condition; the treatment is adjunct to an existing treatment option, and the treatment is not medically contra-indicated. * Sufficient efficacy and safety evidence exists to make a benefit-risk analysis consistent with this policy and the potential patient benefit justifies any potential risks of treatment. * Sufficient clinical data are available to identify an appropriate dose and treatment duration. * The patient's treating physician and qualified medical personnel at Agenus agree there is sufficient evidence to assume the potential benefit to the patient justifies potential risks. * The patient is not eligible for participation in an ongoing clinical trial of the investigational medicine, including lack of access due to geographic limitations. * Expanded Access will not adversely impact any clinical development program, in particular, the conduct of a pivotal clinical trial that is required for regulatory approval. * The request must be made by the patient's treating physician. Note: Other defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm hepatocellular carcinoma malignant pancreatic neoplasm melanoma non-small cell lung carcinoma ovarian cancer pancreatic neoplasm prostate cancer sarcoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colorectal cancer (CRC) Hepatocellular carcinoma (HCC) Melanoma Non-small cell lung cancer (NSCLC) Ovarian cancer Pancreatic cancer Prostate cancer Sarcoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.