Active — Not RecruitingPhase 1/2

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

United States383 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 range18 Years – 99 Years

SexALL

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.
✕. 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.

What they're measuring

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)

Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

Timeframe: Day 1 (baseline) through 246.9 weeks (maximum observed duration)

Change From Baseline in Respiratory Rate (RR)

Timeframe: Day 1 (baseline) through 246.9 weeks (maximum observed duration)

Change From Baseline in Pulse Rate (PR)

Timeframe: Day 1 (baseline) through 246.9 weeks (maximum observed duration)

Change From Baseline in Body Temperature (BT)

Timeframe: Day 1 (baseline) through 246.9 weeks (maximum observed duration)

Change From Baseline in Oxygen Saturation (OS)

Timeframe: Day 1 (baseline) through 246.9 weeks (maximum observed duration)

Number of Participants With Notable Change in QTcF and QTcB From Baseline

Timeframe: Day 1 (baseline) through 246.9 weeks (maximum observed duration)

Trial details

NCT IDNCT02671435

SponsorMedImmune LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-10-26

Results submitted2022-10-21

View on ClinicalTrials.gov More Advanced Solid Tumors trials

Plain-language summary

Who can participate

Age range18 Years – 99 Years

SexALL

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.
✕. 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.

What they're measuring

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)

Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

Timeframe: Day 1 (baseline) through 246.9 weeks (maximum observed duration)

Change From Baseline in Respiratory Rate (RR)

Timeframe: Day 1 (baseline) through 246.9 weeks (maximum observed duration)

Change From Baseline in Pulse Rate (PR)

Timeframe: Day 1 (baseline) through 246.9 weeks (maximum observed duration)

Change From Baseline in Body Temperature (BT)

Timeframe: Day 1 (baseline) through 246.9 weeks (maximum observed duration)

Change From Baseline in Oxygen Saturation (OS)

Timeframe: Day 1 (baseline) through 246.9 weeks (maximum observed duration)

Number of Participants With Notable Change in QTcF and QTcB From Baseline

Timeframe: Day 1 (baseline) through 246.9 weeks (maximum observed duration)