NCT02671435Active, not recruitingPhase 1/2
A Study of Durvalumab (MEDI4736) and Monalizumab in Solid Tumors
A Phase 1/2 Study of Durvalumab and Monalizumab in Adult Subjects With Select Advanced Solid Tumors
Source: ClinicalTrials.gov · Last updated 15 Jun 2026
Brief summary (registry, in English)
This is a multicenter, open-label, dose-escalation, dose-exploration and dose-expansion study to evaluate the safety, tolerability, antitumor activity, pharmacokinetic (PK), pharmacodynamics, and immunogenicity of durvalumab (MEDI4736) in combination with monalizumab (IPH2201) in adult participants with selected advanced solid tumors and the combination of durvalumab and monalizumab (IPH2201) standard of care systemic therapy with or without biological agent and monalizumab (IPH2201) with biological agent administered to participants with recurrent or metastatic colorectal cancer (CRC).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 383 (actual)
- First submitted
- 28 Jan 2016
- Start date
- 22 Feb 2016
- Primary completion date
- 26 Oct 2021
- Lead sponsor
- MedImmune LLC
- Diseases
- Colorectal cancer
- NCT number
- NCT02671435
- EudraCT number
- 2016-000662-38
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 383
- From 22 Feb 2016 to the primary completion date, 26 Oct 2021
- 43 sites in 11 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with immunotherapy agents. Prior treatment with antitumor vaccines may be permitted upon discussion with the medical monitor.
- Prior participation in clinical studies that include durvalumab alone or in combination, where the study has registrational intent and the analyses for the primary endpoint have not yet been completed
- Receipt of any conventional or investigational anticancer therapy within 4 weeks prior to the first dose of study treatment
- Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment. Concurrent use of hormones for non-cancer-related conditions is acceptable.
Who the study is looking for
- Participants must have histologic documentation of advanced recurrent or metastatic cancer.
- Participants must be at the recurrent/metastatic setting, with selected advanced solid tumors.
- Participants must have at least one lesion that is measurable by RECIST v1.1
- Part 3, Dose exploration, CRC participants can be treatment naïve but should not have received more than two line of systemic therapy in the recurrent/metastatic setting.
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (43)
Sites in registry order. Save your city in your profile to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.