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Immunotherapy boosts standard treatment for rectal cancer?

NCT ID NCT03921684

Disease control Sponsor: Baruch Brenner 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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 phase 2 trial tests whether adding the immunotherapy drug nivolumab (Opdivo) to standard chemoradiation and chemotherapy can improve outcomes for people with locally advanced rectal cancer. About 29 participants who have not had prior treatment will receive chemoradiation, then six cycles of chemo plus nivolumab, followed by surgery. The main goal is to see how many patients have no cancer left at the time of surgery.

What this could mean

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

Active substance
nivolumab (Opdivo) plus chemotherapy (capecitabine, oxaliplatin, leucovorin, fluorouracil) and radiation
What this could lead to
If successful, this combination could increase the chance of eliminating all cancer before surgery, potentially allowing some patients to avoid surgery altogether.
What could go wrong
This is a small, early-phase trial with only 29 participants, so results may not apply broadly. Adding immunotherapy to chemotherapy also raises the risk of immune-related side effects.

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.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

29 people

The number who actually took part.

Started

Apr 2019

Expected to finish

Oct 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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.

Inclusion Criteria: * Signed written IRB approved informed consent * Age ≥ 18 years * ECOG PS 0-1 * Subjects with histologically confirmed primary (non-recurrent) locally advanced rectal adenocarcinoma * Stage T3-4 N0 or TX N+ according to baseline rectal EUS and PET-CT * Patients who are planned for neoadjuvant chemoradiation and are surgical candidates * No prior chemotherapy, radiotherapy or surgery for rectal cancer * No prior radiotherapy to the pelvis, for any reason * Presence of adequate contraception in fertile patients * Women of childbearing potential must have a negative serum or urine pregnancy test within 24 hours prior to the start of study drug * Women must not be breastfeeding * Ability to swallow tablets * No previous (within the last 5 years) or concurrent malignancies, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix or basal cell carcinoma of the skin Exclusion Criteria: * Active autoimmune disease. \[Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll\] * Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways * Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) * Pregnancy or breastfeeding

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Conditions

The condition(s) this trial relates to.

rectal cancer rectal neoplasm rectum adenocarcinoma

As listed by the trial registrant

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

Rectal cancer

Contacts and locations

Locations

  • Rabin Medical Center, Beilinson Hospital

    Petah Tikva, Israel

More trials for these conditions

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