A Study of Durvalumab (MEDI4736) and Monalizumab in Solid Tumors (NCT02671435) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
A Study of Durvalumab (MEDI4736) and Monalizumab in Solid Tumors
United States, Australia, Belgium383 participantsStarted 2016-02-22
Plain-language 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).
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participants must have histologic documentation of advanced recurrent or metastatic cancer.
. Participants must be at the recurrent/metastatic setting, with selected advanced solid tumors.
. Participants must have at least one lesion that is measurable by RECIST v1.1
. Part 3, Dose exploration, CRC participants can be treatment naïve but should not have received more than two line of systemic therapy in the recurrent/metastatic setting.
Exclusion criteria
. Prior treatment with immunotherapy agents. Prior treatment with antitumor vaccines may be permitted upon discussion with the medical monitor.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1/2 study primarily measuring safety signals like adverse events, dose-limiting toxicities, and vital sign changes, what does that mean for what's currently known — and not yet known — about how safe this combination of durvalumab and monalizumab might be for someone in my situation?
2The trial is active but no longer enrolling new participants — does that mean there's any chance I could still be considered, or should we focus our energy on finding a comparable study or standard treatment option instead?
3Given that the study is tracking things like heart rhythm changes (QTcF and QTcB), blood pressure, and oxygen saturation as safety measures, are there any existing conditions I have that might make those particular risks more concerning for me?
4The trial includes specific 'exploration cohorts' looking at objective tumor response — do you know which tumor types or cohorts were being studied, and whether my cancer type was among them?
5Compared to what standard treatment options are currently available for my diagnosis, what would be the potential trade-offs of pursuing a combination immunotherapy trial at this stage versus starting with an established therapy first?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Timeframe: Day 1 through 246.9 weeks (maximum observed duration)
2
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Timeframe: Day 1 (baseline) through 246.9 weeks (maximum observed duration)
3
Change From Baseline in Respiratory Rate (RR)
Timeframe: Day 1 (baseline) through 246.9 weeks (maximum observed duration)
4
Change From Baseline in Pulse Rate (PR)
Timeframe: Day 1 (baseline) through 246.9 weeks (maximum observed duration)
5
Change From Baseline in Body Temperature (BT)
Timeframe: Day 1 (baseline) through 246.9 weeks (maximum observed duration)
6
Change From Baseline in Oxygen Saturation (OS)
Timeframe: Day 1 (baseline) through 246.9 weeks (maximum observed duration)
. Prior participation in clinical studies that include durvalumab alone or in combination, where the study has registrational intent and the analyses for the primary endpoint have not yet been completed
. Receipt of any conventional or investigational anticancer therapy within 4 weeks prior to the first dose of study treatment
. Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment. Concurrent use of hormones for non-cancer-related conditions is acceptable.
Number of Participants With Notable Change in QTcF and QTcB From Baseline
Timeframe: Day 1 (baseline) through 246.9 weeks (maximum observed duration)
8
Number of Participants With at Least 2-Grade Shift From Baseline in Laboratory Parameters
Timeframe: Day 1 (baseline) through 246.9 weeks (maximum observed duration)
9
Number of Participants With Dose Limiting Toxicities (DLTs)
Timeframe: From Day 1 to 28 days after the first dose of study drugs
10
Percentage of Participants With Objective Response (OR) in Exploration Cohorts C1A and C1B
Timeframe: Baseline (Days -28 to -1) through 54.8 months (maximum observed duration)