Clinical trial · Interventional
Anti-PD-1 +/- RT for MSI-H Solid Tumors
A Randomized Phase II Study of Anti-PD-1 and Limited Metastatic Site Radiation Therapy Versus Anti-PD-1 Alone for Patients With Microsatellite Instability-high (MSI-H) and Mismatch Repair Deficient (dMMR) Metastatic Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI has decided to withdraw the study
Summary
Brief summary (as posted)
To determine if the out-of-field ORR is improved with the addition of radiation therapy to anti-PD-1 for patients with MSI-H/dMMR metastatic solid tumors. Determine the rates of in-field tumor control, disease control (stable disease, partial response, complete response), durability of disease response, progression-free survival, overall survival, and to assess quality of life and toxicity. Determine the chronology and profile of the radiation-associated immune response.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Microsatellite Instability High | — | UNRESOLVED | — |
| Mismatch Repair Deficiency | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anti-PD-1 | Drug | — | UNRESOLVED |
| RT and Anti-PD-1 | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- RT and Anti-PD-1
- description
- In the pembrolizumab + RT arm, pembrolizumab will be started on study within 7 days (+/- 7 days) of start of RT. Pembrolizumab will be given as standard of care in both arms
- interventionNames
- Combination Product: RT and Anti-PD-1
- type
- PLACEBO_COMPARATOR
- label
- Anti-PD-1
- description
- anti-PD-1 therapy alone Pembrolizumab will be given as standard of care in both arms
- interventionNames
- Drug: Anti-PD-1
Primary outcomes (1)
- measure
- Out-of-field ORR improvement
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: 1. Provision to sign and date the consent form. 2. Stated willingness to comply with all study procedures and be available for the duration of the study. 3. Adult patients, 18-100 years of age. 4. ECOG 0 or 1. 5. Unresectable or metastatic MSI-H/dMMR tumors eligible to receive pembrolizumab according to FDA-approved indications: * Solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options OR * Colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan11 6. Confirmation from medical or gynecologic oncology that the patient is eligible to receive pembrolizumab per FDA-approved indication for patients not currently receiving pembrolizumab . 7. At least one site of disease amenable to radiation therapy per the acceptable dosing regimens outlined in section 6.2, and at least one additional site of measurable disease suitable for out-of-field response assessment. 8. Adequate baseline labs for initiation of trial treatment: * absolute neutrophil count (ANC) \>1,000/µL * platelets \>75,000/µL * hemoglobin \>8 g/dL * serum creatinine \< 1.5 x ULN * serum total bilirubin \< 1.5 x ULN * AST and ALT \< 2.5 x ULN, or \< 5 x ULN if liver metastasis are present Exclusion Criteria: 1. Pregnant women. Pregnancy testing is required for all female subjects of childbearing potential. 2. Patients with active collagen vascular disease (CVD), specifically systemic lupus erythematosus or scleroderma. Patients with a history of CVD without evidence of active disease are eligible for enrollment at the discretion of the study PI. 3. History of immunodeficiency, hypersensitivity to pembrolizumab, or other medical contraindication to receipt of pembrolizumab. 4. Active infection. 5. Active CNS metastases. Patients with treated CNS metastases are eligible. 6. Patients with a separate non-cutaneous cancer diagnosis for which the patient has not been without evidence of disease for at least 5 years.
References
Publications (0)
Data not yet available