Loading
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.
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.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
383 enrolled.
95% CI 0.0 to 10.3; Figures from the ClinicalTrials.gov results section (first posted 2023-03-09), not from a publication · 95% CI 0.0 to 9.0
Source95% CI NA to NA; Figures from the ClinicalTrials.gov results section (first posted 2023-03-09), not from a publication · 95% CI 18.6 to NA · Median and limits of 95% CI could not be derived due to insufficient events being observed. · 95% CI 4.0 to 16.7 · 95% CI 4.4 to 16.9 · 95% CI 6.0 to 20.1 · 95% CI 10.7 to 21.4 · 95% CI 6.7 to 17.3 · 95% CI 5.8 to 15.6 · 95% CI 13.8 to NA · 95% CI 19.8 to NA
Source95% CI 1.7 to NA; Figures from the ClinicalTrials.gov results section (first posted 2023-03-09), not from a publication · 95% CI 1.8 to NA · 95% CI NA to NA · 95% CI 1.7 to 3.4 · 95% CI 1.7 to 3.5 · 95% CI 1.8 to 3.6 · 95% CI 1.7 to 1.9 · 95% CI 1.7 to 3.3 · 95% CI 1.7 to 3.7 · 95% CI 5.7 to 17.7 · 95% CI 5.8 to 20.9
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Percentage of Participants With Objective Response (OR) in Exploration Cohorts C1A and C1Bprimary | Exploration Cohort C1A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W | 40 | 0% | - | - | link |
| Exploration Cohort C1B: Monalizumab 750 mg Q2W + Cetuximab Q2W | 41 | 0% | ||||
| Overall Survival | Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | 3 | 15.1 months | - | - | link |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | 3 | 20.1 months | ||||
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | 3 | Median and limits of 95% CI could not be derived due to insufficient events being observed. | ||||
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | 18 | 8.1 months | ||||
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | 18 | 13.4 months | ||||
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | 40 | 10.6 months | ||||
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | 40 | 16.7 months | ||||
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) | 40 | 11 months | ||||
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | 20 | 8.8 months | ||||
| Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | 18 | 25.6 months | ||||
| Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W | 18 | 29.6 months | ||||
| Progression-Free Survival (PFS) | Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | 3 | 1.8 months | - | - | link |
| Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | 3 | 1.9 months | ||||
| Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | 3 | 1.9 months | ||||
| Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | 18 | 2 months | ||||
| Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | 18 | 1.8 months | ||||
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | 40 | 1.9 months | ||||
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | 40 | 1.8 months | ||||
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) | 40 | 1.8 months | ||||
| Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | 20 | 1.9 months | ||||
| Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | 18 | 10.9 months | ||||
| Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W | 18 | 14.7 months |
Shares Durvalumab, AstraZeneca, Metastatic cancer (cancer that has spread), Immune checkpoint inhibitors and the tag pipeline.
Shares Durvalumab, AstraZeneca, Metastatic cancer (cancer that has spread), Immune checkpoint inhibitors and the tag pipeline.
Shares Durvalumab, AstraZeneca, Metastatic cancer (cancer that has spread), Immune checkpoint inhibitors and the tag pipeline.
Shares Durvalumab, AstraZeneca, Immune checkpoint inhibitors and the tag pipeline.
Shares Durvalumab, AstraZeneca, Immune checkpoint inhibitors and the tag pipeline.
Shares Durvalumab, AstraZeneca, Immune checkpoint inhibitors and the tag pipeline.
Shares Bevacizumab, Metastatic cancer (cancer that has spread), Immune checkpoint inhibitors and the tag pipeline.
Shares Durvalumab, AstraZeneca, Immune checkpoint inhibitors and the tag pipeline.