← Back to Search

Checkpoint Inhibitor

Durvalumab + Monalizumab for Solid Tumors

Phase 1 & 2

Waitlist Available

Research Sponsored by MedImmune LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must have histologic documentation of advanced recurrent or metastatic cancer

Participants must be at the recurrent/metastatic setting, with selected advanced solid tumors

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-dose (pre) on day 1 of weeks 1, 5, 9, 13, and 25 and post-dose (post) on day 1 of weeks 1 and 13

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the safety and effectiveness of two drugs for advanced solid tumor and CRC.

Who is the study for?

This trial is for adults with certain advanced solid tumors that have recurred or spread. Participants must have measurable cancer lesions and can't have had more than two systemic therapies in the recurrent/metastatic setting. They shouldn't have received prior immunotherapy, been in durvalumab trials with pending primary endpoint analysis, or had recent anticancer treatments.

What is being tested?

The study tests Durvalumab combined with Monalizumab's safety and effectiveness against solid tumors. It includes dose-escalation/exploration/expansion phases to find optimal dosages and assess how the body processes these drugs, their impact on the immune system, and potential antitumor activity.

What are the potential side effects?

Potential side effects may include typical reactions to immunotherapies such as fatigue, skin reactions, inflammation of organs (like lungs or intestines), infusion-related symptoms, possible changes in liver function tests, and increased susceptibility to infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My cancer has returned or spread and this is confirmed by tests.

Select...

My cancer has returned or spread to other parts of my body.

Select...

I have colorectal cancer and have had no more than two treatments after it spread.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-dose (pre) on day 1 of weeks 1, 5, 9, 13, and 25 and post-dose (post) on day 1 of weeks 1 and 13

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-dose (pre) on day 1 of weeks 1, 5, 9, 13, and 25 and post-dose (post) on day 1 of weeks 1 and 13

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose (pre) on day 1 of weeks 1, 5, 9, 13, and 25 and post-dose (post) on day 1 of weeks 1 and 13 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change From Baseline in Body Temperature (BT)

Change From Baseline in Oxygen Saturation (OS)

Change From Baseline in Pulse Rate (PR)

+7 more

Secondary study objectives

DoR in Exploration Cohorts (C1A, C1B, C2A, and C2B)

Duration of Response (DoR)

Maximum Observed Serum Concentration (Cmax) of Monalizumab

+16 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

15Treatment groups

Experimental Treatment

Group I: Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2WExperimental Treatment4 Interventions

Participants with 1L MSS-CRC will receive IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W, plus mFOLFOX6 (oxaliplatin 85 mg/m\^2, folinic acid 400 mg/m\^2, fluorouracil 400 mg/m\^2 IV bolus, followed by 2400 mg/m\^2 continuous IV infusion over 46 to 48 hours on Day 1) Q2W plus IV infusion of cetuximab (loading dose of 400 mg/m\^2 on Day 1, followed by maintenance dose of 250 mg/m\^2 IV infusion every week starting on Day 8, then changed to 500 mg/m\^2 IV infusion Q2W) up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

Group II: Exploration Cohort C2B: Monalizumab 750 mg Q2W + Cetuximab Q2WExperimental Treatment2 Interventions

Participants with recurrent or metastatic 3L RAS/BRAF wild type MSS-CRC will receive IV infusion of monalizumab 750 mg Q2W plus IV infusion of cetuximab 500 mg/m\^2 on Day 1 then 500 mg/m\^2 IV infusion Q2W starting on Day 15 up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

Group III: Exploration Cohort C2A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2WExperimental Treatment3 Interventions

Participants with recurrent or metastatic 3L RAS/BRAF wild type MSS-CRC will receive IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W plus IV infusion of cetuximab 500 mg/m\^2 on Day 1 then 500 mg/m\^2 IV infusion Q2W starting on Day 15 up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

Group IV: Exploration Cohort C1B: Monalizumab 750 mg Q2W + Cetuximab Q2WExperimental Treatment2 Interventions

Participants with recurrent or metastatic 3L RAS mutant MSS-CRC will receive IV infusion of monalizumab 750 mg Q2W plus IV infusion of cetuximab 500 mg/m\^2 on Day 1 then 500 mg/m\^2 IV infusion Q2W starting on Day 15 up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

Group V: Exploration Cohort C1A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2WExperimental Treatment3 Interventions

Participants with recurrent or metastatic third-line (3L) RAS mutant MSS-CRC will receive IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W plus IV infusion of cetuximab 500 mg/m\^2 on Day 1 then 500 mg/m\^2 IV infusion Q2W starting on Day 15 up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

Group VI: Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2WExperimental Treatment4 Interventions

Participants with first-line (1L) MSS-CRC will receive IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W plus mFOLFOX (oxaliplatin 85 mg/m\^2 IV infusion, folinic acid 400 mg/m\^2 infusion, fluorouracil 400 mg/m\^2 IV bolus, followed by 2400 mg/m\^2 continuous IV infusion over 46 to 48 hours on Day 1) Q2W plus IV infusion of bevacizumab 5 mg/kg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

Group VII: Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (ovarian)Experimental Treatment2 Interventions

Participants with ovarian cancer will receive IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

Group VIII: Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC)Experimental Treatment2 Interventions

Participants with non-small cell lung cancer (NSCLC) will receive IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

Group IX: Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC)Experimental Treatment2 Interventions

Participants with microsatellite-stable colorectal cancer (MSS-CRC) will receive IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

Group X: Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS)Experimental Treatment2 Interventions

Participants with endometrial MSS will receive IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

Group XI: Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4WExperimental Treatment2 Interventions

Participants will receive IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q4W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

Group XII: Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4WExperimental Treatment2 Interventions

Participants will receive IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 750 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

Group XIII: Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4WExperimental Treatment2 Interventions

Participants will receive IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 225 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

Group XIV: Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4WExperimental Treatment2 Interventions

Participants will receive IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 75 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.

Group XV: Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4WExperimental Treatment2 Interventions

Participants will receive intravenous (IV) infusions of durvalumab 1500 mg every 4 weeks (Q4W) in combination with monalizumab 22.5 mg every 2 weeks (Q2W) up to 3 years until unacceptable toxicity, documentation of confirmed disease progression (PD), or documentation of subject withdrawal for another reason.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

mFOLFOX6

2009

Completed Phase 4

~1600

Durvalumab

2017

Completed Phase 2

~3750