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Immunotherapy combo shows promise for rare cancers, but study halted early

NCT ID NCT02938793

Disease control Sponsor: Prisma Health-Upstate 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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This phase 2 trial tested a combination of two immunotherapy drugs, durvalumab and tremelimumab, in 92 people with advanced rare solid tumors who had no other standard treatment options. The goal was to see if the drugs could shrink tumors and to check for side effects. The study was terminated early, so the full results are not available, but the approach aims to harness the immune system to fight these uncommon cancers.

What this could mean

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

Active substance
durvalumab and tremelimumab (immunotherapy drugs)
What this could lead to
If it works, this could point toward a new treatment option for people with rare cancers that have few standard therapies.
What could go wrong
This was a small, early-phase study that was terminated, so results are limited. Immunotherapy can cause serious immune-related side effects, and not all rare tumors respond to these drugs.

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

92 people

The number who actually took part.

Started

Dec 2016

Finished

Sep 2025

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: * Diagnosis of a rare advanced solid malignancy meeting EORTC criteria. * Subjects must have failed or been ineligible to receive standard treatment options if available. * Subjects must be amenable to biopsy of a tumor site or have recent (\< 2 years) archival material available. * ECOG performance status of 0 to 2. * Life expectancy \> 3 months. * Adequate normal organ and marrow function including: hemoglobin \> 9.0 g/dl; ANC \> 1500 per mm3; platelet count \> 100,000 per mm3; bilirubin \< 1.5 x ULN; ALT/AST \< 2.5 x ULN unless liver metastases present in which case must be \< 5 x ULN; creatinine clearance \> 40 ml/min by Cockcroft-Gault or 24 hour urine collection Exclusion Criteria: * Previous treatment with durvalumab or tremelimumab. * Prior treatment with any checkpoint inhibitor (including anti-CTLA-4, anti-PD-1 and anti-PD-L1). * Rare malignancies under investigation in other studies including thymic carcinoma, certain sarcomas, and neuroendocrine tumors. * Untreated central nervous system metastatic disease. * Active or documented autoimmune disease within previous 2 years. * Uncontrolled psoriasis. * Prior chemotherapy within 28 days of the first dose of durvalumab or tremelimumab. * Steroid exposure within 28 days of the first dose of durvalumab or tremelimumab 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

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Conditions

The condition(s) this trial relates to.

cancer neoplasm Rare Diseases

As listed by the trial registrant

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

Cancer Rare disease

Contacts and locations

Locations

  • Greenville Health System Cancer Institute

    Greenville, South Carolina, 29605, United States

More trials for these conditions

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