Trial · NCT02671435
A Study of Durvalumab (MEDI4736) and Monalizumab in Solid Tumors
NCT02671435, Phase 1, Phase 2, Active not recruiting, MedImmune LLC; results first posted 2023-03-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Durvalumab (MEDI4736) and Monalizumab in Solid Tumors. Trials, record NCT02671435. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02671435
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Durvalumab (MEDI4736) and Monalizumab in Solid Tumors
- NCT number
- NCT02671435
- Status
- Active not recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 383 participants, actual
- Lead sponsor
- MedImmune LLC
- Conditions
- Advanced Solid Tumors
- Interventions
- Monalizumab, Durvalumab, Cetuximab, mFOLFOX6, Bevacizumab
- First posted
- 2016-02-02
- Last updated
- 2026-06-15
- Other registries' IDs
- eudract:2016-000662-38
- Results first posted
- 2023-03-09
Source ClinicalTrials.gov
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Day 1 through 246.9 weeks (maximum observed duration) | 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 baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug. Any TEAEs data is inclusive of both serious and other adverse events (non-serious). |
| Primary | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 1 (baseline) through 246.9 weeks (maximum observed duration) | Change from baseline in SBP and DBP (minimum post baseline change \[PBC\] and maximum PBC) are reported. |
| Primary | Change From Baseline in Respiratory Rate (RR) | Day 1 (baseline) through 246.9 weeks (maximum observed duration) | Change from baseline in RR (minimum PBC and maximum PBC) are reported. |
| Primary | Change From Baseline in Pulse Rate (PR) | Day 1 (baseline) through 246.9 weeks (maximum observed duration) | Change from baseline in PR (minimum PBC and maximum PBC) are reported. |
| Primary | Change From Baseline in Body Temperature (BT) | Day 1 (baseline) through 246.9 weeks (maximum observed duration) | Change from baseline in BT (minimum PBC and maximum PBC) are reported. |
| Primary | Change From Baseline in Oxygen Saturation (OS) | Day 1 (baseline) through 246.9 weeks (maximum observed duration) | Change from baseline in OS (minimum PBC and maximum PBC) are reported. |
| Primary | Number of Participants With Notable Change in QTcF and QTcB From Baseline | Day 1 (baseline) through 246.9 weeks (maximum observed duration) | Participants who had notable QTcF and QTcB interval change from baseline are reported. |
| Primary | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Day 1 (baseline) through 246.9 weeks (maximum observed duration) | Number of participants with at least 2-Grade shift from baseline in laboratory parameters are reported. |
| Primary | Number of Participants With Dose Limiting Toxicities (DLTs) | From Day 1 to 28 days after the first dose of study drugs | DLT: Any study drug related Grade (G) 3 or higher toxicity that occurred during DLT evaluation period including: any G\>=3 noninfectious colitis/pneumonitis, liver transaminase elevation (TE) \>=5 but =\<8 upper limit of normal (ULN), any G4 immune-mediated AE (imAE)/immune-related AE (irAE), any G\>=3 clinically significant non-hematologic toxicity, TE \>8 ULN or total bilirubin (TBL) \>5 ULN, increase in AST or ALT \>=3 ULN along with TBL \>=2 ULN, thrombocytopenia (G3/4 associated with G3/higher hemorrhage, G3 that did not improve by at least 1 grade within 7 days, and G4), G4 febrile neutropenia (FN), G3 FN of \>=5 days and G3 FN regardless of duration, G4 neutropenia of \>7 days, G3/4 neutropenia not associated with fever/systemic infection, and anemia (G3 and G4). |
| Primary | Percentage of Participants With Objective Response (OR) in Exploration Cohorts C1A and C1B | Baseline (Days -28 to -1) through 54.8 months (maximum observed duration) | The OR is defined as best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST V 1.1) guidelines. The CR is defined as disappearance of all target and non-target lesions and normalization of tumor marker level lesions. The PR is defined as at least a 30% decrease in the sum of the diameters of target lesions (compared to baseline) and no new nontarget lesion. A confirmed PR is defined as two PRs or an un-confirmed PR and an unconfirmed CR that were separated by at least 28 days with no evidence of progression in between. |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 registered outcomesOutcomes29
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Day 1 through 246.9 weeks (maximum observed duration) | As-treated population included participants who received any study drugs and were analyzed according to the treatment they actually received. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 1 (baseline) through 246.9 weeks (maximum observed duration) | As-treated population included participants who received any study drugs and were analyzed according to the treatment they actually received. | mmHg | MEAN |
| PRIMARY | Change From Baseline in Respiratory Rate (RR) | Day 1 (baseline) through 246.9 weeks (maximum observed duration) | As-treated population included participants who received any study drugs and were analyzed according to the treatment they actually received. | breaths/min | MEAN |
| PRIMARY | Change From Baseline in Pulse Rate (PR) | Day 1 (baseline) through 246.9 weeks (maximum observed duration) | As-treated population included participants who received any study drugs and were analyzed according to the treatment they actually received. Here, number of participants analyzed (N) denotes those participants who were evaluable for this outcome. | beats/min | MEAN |
| PRIMARY | Change From Baseline in Body Temperature (BT) | Day 1 (baseline) through 246.9 weeks (maximum observed duration) | As-treated population included participants who received any study drugs and were analyzed according to the treatment they actually received. | degree Celsius | MEAN |
| PRIMARY | Change From Baseline in Oxygen Saturation (OS) | Day 1 (baseline) through 246.9 weeks (maximum observed duration) | As-treated population included participants who received any study drugs and were analyzed according to the treatment they actually received. Here, number of participants analyzed (N) denotes those participants who were evaluable for this outcome. | Percentage of oxygen saturation | MEAN |
| PRIMARY | Number of Participants With Notable Change in QTcF and QTcB From Baseline | Day 1 (baseline) through 246.9 weeks (maximum observed duration) | As-treated population included participants who received any study drugs and were analyzed according to the treatment they actually received. Here, number of participants analyzed (N) denotes those participants who were evaluable for this outcome. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters | Day 1 (baseline) through 246.9 weeks (maximum observed duration) | As-treated population included participants who received any study drugs and were analyzed according to the treatment they actually received. Here, number analyzed (n) denotes number of participants analyzed for the specified laboratory parameter. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Dose Limiting Toxicities (DLTs) | From Day 1 to 28 days after the first dose of study drugs | The DLT-Evaluable population included all participants enrolled in the dose-escalation part who received at least 1 dose of study drugs and completed the safety follow-up through the DLT-evaluation period or experienced any DLT during the DLT-evaluation period. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Percentage of Participants With Objective Response (OR) in Exploration Cohorts C1A and C1B | Baseline (Days -28 to -1) through 54.8 months (maximum observed duration) | The ITT population included participants who were randomized and were analyzed according to the treatment group they were randomized to. | Percentage of Participants | NUMBER |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 outcomesResults by group870
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | Any TEAEs | 3 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | Any TEAEs | 3 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | Any TEAEs | 3 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | Any TEAEs | 18 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | Any TEAEs | 17 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | Any TEAEs | 39 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | Any TEAEs | 40 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) | Any TEAEs | 39 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | Any TEAEs | 20 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | Any TEAEs | 18 | Participants |
1 to 10 of 870Source ClinicalTrials.gov
See all 870 results by groupParticipant flow60
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | 3 | |
| Overall Study | STARTED | Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | 3 | |
| Overall Study | STARTED | Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | 3 | |
| Overall Study | STARTED | Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | 18 | |
| Overall Study | STARTED | Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | 18 | |
| Overall Study | STARTED | Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | 40 | |
| Overall Study | STARTED | Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | 40 | |
| Overall Study | STARTED | Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) | 40 | |
| Overall Study | STARTED | Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | 20 | |
| Overall Study | STARTED | Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | 18 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 participant flowAdverse events9,345
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Acute myocardial infarction | Cardiac disorders | Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | 0 | 3 | 0 |
| other | Acute myocardial infarction | Cardiac disorders | Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | 0 | 3 | 0 |
| other | Acute myocardial infarction | Cardiac disorders | Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | 0 | 3 | 0 |
| other | Acute myocardial infarction | Cardiac disorders | Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | 0 | 18 | 0 |
| other | Acute myocardial infarction | Cardiac disorders | Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | 0 | 18 | 0 |
| other | Acute myocardial infarction | Cardiac disorders | Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | 0 | 40 | 0 |
| other | Acute myocardial infarction | Cardiac disorders | Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | 0 | 40 | 0 |
| other | Acute myocardial infarction | Cardiac disorders | Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) | 0 | 40 | 0 |
| other | Acute myocardial infarction | Cardiac disorders | Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | 0 | 20 | 0 |
| other | Acute myocardial infarction | Cardiac disorders | Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | 0 | 18 | 0 |
1 to 10 of 9,345Source ClinicalTrials.gov
See all 9,345 adverse eventsAdverse event totals45
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W | 1 | 3 |
| Total, all-cause mortality | Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W | 3 | 3 |
| Total, all-cause mortality | Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W | 0 | 3 |
| Total, all-cause mortality | Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W | 16 | 18 |
| Total, all-cause mortality | Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W | 14 | 18 |
| Total, all-cause mortality | Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC) | 29 | 40 |
| Total, all-cause mortality | Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Ovarian) | 34 | 40 |
| Total, all-cause mortality | Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS) | 28 | 40 |
| Total, all-cause mortality | Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC) | 19 | 20 |
| Total, all-cause mortality | Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W | 10 | 18 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02671435
GET https://conductscience.org/api/trials/v1/NCT02671435/registered?page=2