Clinical trial · Interventional
Durvalumab in Combination With Tremelimumab in Subjects With Advanced Rare Solid Tumors
A Phase II Study of Durvalumab (MEDI4736) (Anti-PD-L1 Antibody) in Combination With Tremelimumab (Anti-CTLA-4 Antibody) in Subjects With Advanced Rare Solid Tumors
NCT02938793CI-TRIAL-00095647terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): poor enrollment likely due to expanded availability of immunotherapy for patients
Summary
Brief summary (as posted)
This is an investigator initiated single institution, open-label study to evaluate the antitumor activity, safety, and tolerability of durvalumab in combination with tremelimumab in subjects with select advanced rare solid tumors.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Rare Disease | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Durvalumab | Drug | Durvalumab | ALIAS |
| Tremelimumab | Drug | Tremelimumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Arm
- description
- Durvalumab, 1500 mg Q4W (equivalent to 20 mg/kg Q4W) intravenously for 13 doses and Tremelimumab 300mg intravenously as a single dose on cycle 1 day 1 only.
- interventionNames
- Drug: Durvalumab
- Drug: Tremelimumab
Primary outcomes (2)
- measure
- Antitumor Activity
- timeFrame
- 24 months
- description
- To evaluate the antitumor activity of durvalumab in combination with tremelimumab based on immune-related Response Evaluation Criteria
- measure
- Incidence of Treatment-Emergent and Non Treatment-Emergent Adverse Events [Safety and Tolerability]
- timeFrame
- 24 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTEdenfield WJ, Chung K, O'Rourke M, Cull E, Martin J, Bowers H, Smith W, Gluck WL. A Phase II Study of Durvalumab in Combination with Tremelimumab in Patients with Rare Cancers. Oncologist. 2021 Sep;26(9):e1499-e1507. doi: 10.1002/onco.13798. Epub 2021 May 8. PMID 33893692