# A Study of Durvalumab (MEDI4736) and Monalizumab in Solid Tumors

Source: https://onco.cc/trials/nct02671435/  
OnCo record `nct02671435` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 1/2 trial of Monalizumab, Durvalumab, Cetuximab, FOLFOX (5-FU, leucovorin, oxaliplatin) and Bevacizumab in advanced solid tumours, run by MedImmune LLC, active and no longer recruiting.

## Summary

A Study of Durvalumab (MEDI4736) and Monalizumab in Solid Tumors is a phase 1/2 interventional study registered as NCT02671435 by MedImmune LLC, with 383 participants enrolled, started 2016-02-22 and due to reach its primary completion in 2021-10-26. Interventions recorded: Monalizumab, Durvalumab, Cetuximab, mFOLFOX6 and Bevacizumab. Results have been posted on the registry.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-22
- Tags: pipeline; ctgov-ingest
- Registry id: NCT02671435
- Phase: 1/2
- Setting: A Phase 1/2 Study of Durvalumab and Monalizumab in Adult Subjects With Select Advanced Solid Tumors
- Sponsor: MedImmune LLC
- Enrolled: 383
- Outcomes: Percentage of Participants With Objective Response (OR) in Exploration Cohorts C1A and C1B: Exploration Cohort C1A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W 0% vs Exploration Cohort C1B: Monalizumab 750 mg Q2W + Cetuximab Q2W 0%; Overall Survival: Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W 15.1 months vs Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W 20.1 months vs Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W vs Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W 8.1 months vs Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W 13.4 months vs Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) 10.6 months vs Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) 16.7 months vs Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) 11 months vs Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) 8.8 months vs Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W 25.6 months vs Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W 29.6 months; Progression-Free Survival (PFS): Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W 1.8 months vs Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W 1.9 months vs Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W 1.9 months vs Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W 2 months vs Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W 1.8 months vs Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) 1.9 months vs Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) 1.8 months vs Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) 1.8 months vs Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) 1.9 months vs Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W 10.9 months vs Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W 14.7 months

## Sources

- ClinicalTrials.gov NCT02671435: https://clinicaltrials.gov/study/NCT02671435

## Connected records

- cancers: [Metastatic cancer (cancer that has spread)](https://onco.cc/cancers/metastatic-cancer/)
- technologies: [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/)
- drugs: [Bevacizumab](https://onco.cc/drugs/bevacizumab/), [Cetuximab](https://onco.cc/drugs/cetuximab/), [Durvalumab](https://onco.cc/drugs/durvalumab/), [FOLFOX (5-FU, leucovorin, oxaliplatin)](https://onco.cc/drugs/folfox/), [Monalizumab](https://onco.cc/drugs/monalizumab/)
- companies: [AstraZeneca](https://onco.cc/companies/astrazeneca/)

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