{"entity":{"id":"nct02671435","kind":"trial","name":"A Study of Durvalumab (MEDI4736) and Monalizumab in Solid Tumors","aka":[],"tldr":"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.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02671435","url":"https://clinicaltrials.gov/study/NCT02671435"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["monalizumab","durvalumab","cetuximab","folfox","bevacizumab"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"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","started":"2016-02-22","startedType":"actual","yearReported":2023,"enrolled":383,"enrolledBasis":"registry","outcomes":[{"endpoint":"Percentage of Participants With Objective Response (OR) in Exploration Cohorts C1A and C1B","primary":true,"unit":"%","arms":[{"name":"Exploration Cohort C1A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W","n":40,"value":0,"note":"95% CI 0.0 to 10.3; Figures from the ClinicalTrials.gov results section (first posted 2023-03-09), not from a publication"},{"name":"Exploration Cohort C1B: Monalizumab 750 mg Q2W + Cetuximab Q2W","n":41,"value":0,"note":"95% CI 0.0 to 9.0"}],"source":"https://clinicaltrials.gov/study/NCT02671435?tab=results"},{"endpoint":"Overall Survival","unit":"months","arms":[{"name":"Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W","n":3,"value":15.1,"note":"95% CI NA to NA; Figures from the ClinicalTrials.gov results section (first posted 2023-03-09), not from a publication"},{"name":"Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W","n":3,"value":20.1,"note":"95% CI 18.6 to NA"},{"name":"Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W","n":3,"note":"Median and limits of 95% CI could not be derived due to insufficient events being observed."},{"name":"Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W","n":18,"value":8.1,"note":"95% CI 4.0 to 16.7"},{"name":"Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W","n":18,"value":13.4,"note":"95% CI 4.4 to 16.9"},{"name":"Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC)","n":40,"value":10.6,"note":"95% CI 6.0 to 20.1"},{"name":"Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian)","n":40,"value":16.7,"note":"95% CI 10.7 to 21.4"},{"name":"Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS)","n":40,"value":11,"note":"95% CI 6.7 to 17.3"},{"name":"Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC)","n":20,"value":8.8,"note":"95% CI 5.8 to 15.6"},{"name":"Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W","n":18,"value":25.6,"note":"95% CI 13.8 to NA"},{"name":"Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W","n":18,"value":29.6,"note":"95% CI 19.8 to NA"}],"source":"https://clinicaltrials.gov/study/NCT02671435?tab=results"},{"endpoint":"Progression-Free Survival (PFS)","unit":"months","arms":[{"name":"Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W","n":3,"value":1.8,"note":"95% CI 1.7 to NA; Figures from the ClinicalTrials.gov results section (first posted 2023-03-09), not from a publication"},{"name":"Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W","n":3,"value":1.9,"note":"95% CI 1.8 to NA"},{"name":"Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W","n":3,"value":1.9,"note":"95% CI NA to NA"},{"name":"Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W","n":18,"value":2,"note":"95% CI 1.7 to 3.4"},{"name":"Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W","n":18,"value":1.8,"note":"95% CI 1.7 to 3.5"},{"name":"Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC)","n":40,"value":1.9,"note":"95% CI 1.8 to 3.6"},{"name":"Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian)","n":40,"value":1.8,"note":"95% CI 1.7 to 1.9"},{"name":"Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS)","n":40,"value":1.8,"note":"95% CI 1.7 to 3.3"},{"name":"Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC)","n":20,"value":1.9,"note":"95% CI 1.7 to 3.7"},{"name":"Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W","n":18,"value":10.9,"note":"95% CI 5.7 to 17.7"},{"name":"Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W","n":18,"value":14.7,"note":"95% CI 5.8 to 20.9"}],"source":"https://clinicaltrials.gov/study/NCT02671435?tab=results"}]},"route":"/trials/nct02671435/","neighbours":{"cancer":[{"id":"metastatic-cancer","kind":"cancer","name":"Metastatic cancer (cancer that has spread)","route":"/cancers/metastatic-cancer/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"drug":[{"id":"bevacizumab","kind":"drug","name":"Bevacizumab","route":"/drugs/bevacizumab/"},{"id":"cetuximab","kind":"drug","name":"Cetuximab","route":"/drugs/cetuximab/"},{"id":"durvalumab","kind":"drug","name":"Durvalumab","route":"/drugs/durvalumab/"},{"id":"folfox","kind":"drug","name":"FOLFOX (5-FU, leucovorin, oxaliplatin)","route":"/drugs/folfox/"},{"id":"monalizumab","kind":"drug","name":"Monalizumab","route":"/drugs/monalizumab/"}],"company":[{"id":"astrazeneca","kind":"company","name":"AstraZeneca","route":"/companies/astrazeneca/"}]}}