Clinical trial · Interventional
A Phase 1 Study of MEDI4736 in Combination With Tremelimumab in Subjects With Advanced Solid Tumors
A Phase I Study of MEDI4736 (Anti-PD-L1 Antibody) in Combination With Tremelimumab (Anti-CTLA-4 Antibody) in Subjects With Advanced Solid Tumors
NCT02261220CI-TRIAL-00043844completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a multicenter, open-label, dose-exploration and dose-expansion study to evaluate the safety, tolerability, antitumor activity, PK and immunogenicity of MEDI4736 in combination with tremelimumab in subjects with select advanced solid tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MEDI4736 | Biological | Durvalumab | ALIAS |
| tremelimumab | Biological | Tremelimumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MEDI4736 + Tremelimumab
- description
- Subjects with multiple tumor types.
- interventionNames
- Biological: MEDI4736
- Biological: tremelimumab
Primary outcomes (7)
- measure
- Number of subjects reporting adverse events
- timeFrame
- Screening through 15 months after the last subject enters re-treatment
- measure
- Number of subjects reporting serious adverse events
- timeFrame
- Screening through 15 months after the last subject enters re-treatment
- measure
- Number of subjects experiencing a dose-limiting toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Male and female subjects * 18 years and older * Histologic confirmation of advanced solid tumors * Subjects must have recurrent/metastatic disease and may have been previously treated in the recurrent/metastatic setting. Exclusion Criteria: * Any concurrent chemotherapy, immune-mediated therapy or biologic or hormonal therapy for cancer treatment * Active or prior documented autoimmune disease within the past 2 years * Current or prior use of immunosuppressive medication within 14 days with some exceptions.
References
Publications (1)
- DERIVEDZhang Q, Luo J, Wu S, Si H, Gao C, Xu W, Abdullah SE, Higgs BW, Dennis PA, van der Heijden MS, Segal NH, Chaft JE, Hembrough T, Barrett JC, Hellmann MD. Prognostic and Predictive Impact of Circulating Tumor DNA in Patients with Advanced Cancers Treated with Immune Checkpoint Blockade. Cancer Discov. 2020 Dec;10(12):1842-1853. doi: 10.1158/2159-8290.CD-20-0047. Epub 2020 Aug 14. PMID 32816849