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NCT02671435 · ClinicalTrials.gov registry record · Phase 1
A Study of Durvalumab (MEDI4736) and Monalizumab in Solid Tumors
A Phase 1 study of Advanced Solid Tumors, sponsored by MedImmune.
- Active
- Registry status
- Phase 1
- Development phase
- 383
- Enrollment target
- 20
- Study locations
NCT02671435: Active Phase 1 study of Advanced Solid Tumors, sponsored by MedImmune.
NCT02671435 is a Phase 1 study of Advanced Solid Tumors that is active but no longer recruiting, run by MedImmune. The registered enrollment target is 383 participants, above the 196-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (95% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02671435, a Phase 1 study of Advanced Solid Tumors, is active but no longer recruiting, sponsored by MedImmune.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 383 participants
- Enrollment target
- 20
- Study locations
Study Summary
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).
Primary Outcome
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at
Conditions Studied
Interventions
- DRUG Bevacizumab
- DRUG Cetuximab
- DRUG Durvalumab
- DRUG Monalizumab
- DRUG mFOLFOX6
Study Locations (20)
California
- Research Site - Duarte
- Research Site - La Jolla
- Research Site - Los Angeles
- Research Site - Sacramento
- Research Site - Santa Monica
New York
- Research Site - New Hyde Park
- Research Site - New York
- Research Site - The Bronx
Alabama
- Research Site - Birmingham
Arizona
- Research Site - Scottsdale
Colorado
- Research Site - Aurora
Florida
- Research Site - Tampa
Illinois
- Research Site - Chicago
Maryland
- Research Site - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 383 participants |
| Start Date | 2016-02-22 |
| Est. Completion | 2025-09-01 |
| Phase | Phase 1 |
What the registry record for NCT02671435 still lists
NCT02671435 is an interventional study that assigns participants to a tested intervention. The registered 383 participants enrollment target is mid-sized for trials with a published cap, above the 196-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (95% higher).
The record links to 1 condition, with Advanced Solid Tumors appearing as the primary indexed condition, and to 5 interventions - of which Bevacizumab is the first listed.
NCT02671435 names 20 study sites across 14 states, led by California, New York, Alabama.
Frequently Asked Questions
What is clinical trial NCT02671435 about?
NCT02671435 is a clinical study titled "A Study of Durvalumab (MEDI4736) and Monalizumab in Solid Tumors". 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 ...
What is the current status of trial NCT02671435?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 383 participants. The study started on 2016-02-22. Estimated completion is 2025-09-01.
What conditions does trial NCT02671435 study?
This clinical trial studies the following conditions: Advanced Solid Tumors.
What interventions are being tested in trial NCT02671435?
The interventions under investigation include: Bevacizumab (DRUG), Cetuximab (DRUG), Durvalumab (DRUG), Monalizumab (DRUG), mFOLFOX6 (DRUG).
Who is sponsoring clinical trial NCT02671435?
This trial is sponsored by MedImmune, which has 210 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02671435 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Advanced Solid Tumors
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02671435's enrollment target sits among peer trials
383 15th of 144 higher than 130 of 144 other Advanced Solid Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Solid Tumors trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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