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

NCT ID: NCT02671435

Last Updated: 2025-07-22

Study Results

Results available

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

383 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-22

Study Completion Date

2025-09-01

Brief Summary

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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).

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Detailed Description

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The study consists of 3 parts: dose escalation (Part 1), dose expansion (Part 2), and dose exploration (Part 3). Part 1 will evaluate dose escalation of durvalumab in combination with monalizumab in adult participants with select advanced solid tumor malignancies. Part 2 will evaluate further the identified dose of durvalumab in combination with monalizumab from Part 1 in adult participants with select advanced solid tumor malignancies. Part 3 will evaluate dose exploration of durvalumab in combination with monalizumab and standard of care systemic therapy with or without biological agent, and monalizumab in combination with biological agent in adult participants with CRC.

Conditions

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Advanced Solid Tumors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W

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.

Group Type EXPERIMENTAL

Monalizumab

Intervention Type DRUG

Participants will receive IV infusion of monalizumab as stated in arm description.

Durvalumab

Intervention Type DRUG

Participants will receive IV infusion of durvalumab as stated in arm description.

Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W

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 Type EXPERIMENTAL

Monalizumab

Intervention Type DRUG

Participants will receive IV infusion of monalizumab as stated in arm description.

Durvalumab

Intervention Type DRUG

Participants will receive IV infusion of durvalumab as stated in arm description.

Dose-escalation Cohort 3: Monalizumab 225 mg Q2W + Durvalumab 1500 mg Q4W

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 Type EXPERIMENTAL

Monalizumab

Intervention Type DRUG

Participants will receive IV infusion of monalizumab as stated in arm description.

Durvalumab

Intervention Type DRUG

Participants will receive IV infusion of durvalumab as stated in arm description.

Dose-escalation Cohort 4: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W

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 Type EXPERIMENTAL

Monalizumab

Intervention Type DRUG

Participants will receive IV infusion of monalizumab as stated in arm description.

Durvalumab

Intervention Type DRUG

Participants will receive IV infusion of durvalumab as stated in arm description.

Dose-escalation Cohort 5: Monalizumab 750 mg Q4W + Durvalumab 1500 mg Q4W

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 Type EXPERIMENTAL

Monalizumab

Intervention Type DRUG

Participants will receive IV infusion of monalizumab as stated in arm description.

Durvalumab

Intervention Type DRUG

Participants will receive IV infusion of durvalumab as stated in arm description.

Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (MSS-CRC)

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 Type EXPERIMENTAL

Monalizumab

Intervention Type DRUG

Participants will receive IV infusion of monalizumab as stated in arm description.

Durvalumab

Intervention Type DRUG

Participants will receive IV infusion of durvalumab as stated in arm description.

Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (ovarian)

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 Type EXPERIMENTAL

Monalizumab

Intervention Type DRUG

Participants will receive IV infusion of monalizumab as stated in arm description.

Durvalumab

Intervention Type DRUG

Participants will receive IV infusion of durvalumab as stated in arm description.

Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (Endometrial MSS)

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 Type EXPERIMENTAL

Monalizumab

Intervention Type DRUG

Participants will receive IV infusion of monalizumab as stated in arm description.

Durvalumab

Intervention Type DRUG

Participants will receive IV infusion of durvalumab as stated in arm description.

Dose-expansion Cohort: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W (NSCLC)

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 Type EXPERIMENTAL

Monalizumab

Intervention Type DRUG

Participants will receive IV infusion of monalizumab as stated in arm description.

Durvalumab

Intervention Type DRUG

Participants will receive IV infusion of durvalumab as stated in arm description.

Exploration Cohort A1: Monalizumab 750 mg Q2W+Durvalumab 1500 mg Q4W+mFOLFOX6 Q2W+Bevacizumab Q2W

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 Type EXPERIMENTAL

Monalizumab

Intervention Type DRUG

Participants will receive IV infusion of monalizumab as stated in arm description.

Durvalumab

Intervention Type DRUG

Participants will receive IV infusion of durvalumab as stated in arm description.

mFOLFOX6

Intervention Type DRUG

Participants will receive IV infusion of mFOLFOX as stated in arm description.

Bevacizumab

Intervention Type DRUG

Participants will receive IV infusion of bevacizumab as stated in arm description.

Exploration CohortA2: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + mFOLFOX6 Q2W + Cetuximab Q2W

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 Type EXPERIMENTAL

Monalizumab

Intervention Type DRUG

Participants will receive IV infusion of monalizumab as stated in arm description.

Durvalumab

Intervention Type DRUG

Participants will receive IV infusion of durvalumab as stated in arm description.

Cetuximab

Intervention Type DRUG

Participants will receive IV infusion of cetuximab as stated in arm description.

mFOLFOX6

Intervention Type DRUG

Participants will receive IV infusion of mFOLFOX as stated in arm description.

Exploration Cohort C1A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W

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 Type EXPERIMENTAL

Monalizumab

Intervention Type DRUG

Participants will receive IV infusion of monalizumab as stated in arm description.

Durvalumab

Intervention Type DRUG

Participants will receive IV infusion of durvalumab as stated in arm description.

Cetuximab

Intervention Type DRUG

Participants will receive IV infusion of cetuximab as stated in arm description.

Exploration Cohort C1B: Monalizumab 750 mg Q2W + Cetuximab Q2W

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 Type EXPERIMENTAL

Monalizumab

Intervention Type DRUG

Participants will receive IV infusion of monalizumab as stated in arm description.

Cetuximab

Intervention Type DRUG

Participants will receive IV infusion of cetuximab as stated in arm description.

Exploration Cohort C2A: Monalizumab 750 mg Q2W + Durvalumab 1500 mg Q4W + Cetuximab Q2W

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 Type EXPERIMENTAL

Monalizumab

Intervention Type DRUG

Participants will receive IV infusion of monalizumab as stated in arm description.

Durvalumab

Intervention Type DRUG

Participants will receive IV infusion of durvalumab as stated in arm description.

Cetuximab

Intervention Type DRUG

Participants will receive IV infusion of cetuximab as stated in arm description.

Exploration Cohort C2B: Monalizumab 750 mg Q2W + Cetuximab Q2W

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 Type EXPERIMENTAL

Monalizumab

Intervention Type DRUG

Participants will receive IV infusion of monalizumab as stated in arm description.

Cetuximab

Intervention Type DRUG

Participants will receive IV infusion of cetuximab as stated in arm description.

Interventions

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Monalizumab

Participants will receive IV infusion of monalizumab as stated in arm description.

Intervention Type DRUG

Durvalumab

Participants will receive IV infusion of durvalumab as stated in arm description.

Intervention Type DRUG

Cetuximab

Participants will receive IV infusion of cetuximab as stated in arm description.

Intervention Type DRUG

mFOLFOX6

Participants will receive IV infusion of mFOLFOX as stated in arm description.

Intervention Type DRUG

Bevacizumab

Participants will receive IV infusion of bevacizumab as stated in arm description.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Participants must have histologic documentation of advanced recurrent or metastatic cancer.
2. Participants must be at the recurrent/metastatic setting, with selected advanced solid tumors.
3. Participants must have at least one lesion that is measurable by RECIST v1.1
4. 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

1. Prior treatment with immunotherapy agents. Prior treatment with antitumor vaccines may be permitted upon discussion with the medical monitor.
2. 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
3. Receipt of any conventional or investigational anticancer therapy within 4 weeks prior to the first dose of study treatment
4. Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment. Concurrent use of hormones for non-cancer-related conditions is acceptable.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MedImmune LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Birmingham, Alabama, United States

Site Status

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Scottsdale, Arizona, United States

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Duarte, California, United States

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La Jolla, California, United States

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Los Angeles, California, United States

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Sacramento, California, United States

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Santa Monica, California, United States

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Aurora, Colorado, United States

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Tampa, Florida, United States

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Chicago, Illinois, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Detroit, Michigan, United States

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New Brunswick, New Jersey, United States

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New Hyde Park, New York, United States

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New York, New York, United States

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The Bronx, New York, United States

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Providence, Rhode Island, United States

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Nashville, Tennessee, United States

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Dallas, Texas, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Blacktown, , Australia

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Clayton, , Australia

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Waratah, , Australia

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Brussels, , Belgium

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Edegem, , Belgium

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Leuven, , Belgium

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Vancouver, British Columbia, Canada

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Toronto, Ontario, Canada

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Marseille, , France

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Nantes, , France

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Debrecen, , Hungary

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Milan, , Italy

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Milan, , Italy

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Grafton, , New Zealand

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Barcelona, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Málaga, , Spain

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Pamplona, , Spain

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Seville, , Spain

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London, , United Kingdom

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Sutton, , United Kingdom

Site Status

Countries

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United States Australia Belgium Canada France Hungary Italy New Zealand South Korea Spain United Kingdom

References

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Patel SP, Alonso-Gordoa T, Banerjee S, Wang D, Naidoo J, Standifer NE, Palmer DC, Cheng LY, Kourtesis P, Ascierto ML, Das M, Diamond JR, Hellmann MD, Carneiro BA. Phase 1/2 study of monalizumab plus durvalumab in patients with advanced solid tumors. J Immunother Cancer. 2024 Feb 2;12(2):e007340. doi: 10.1136/jitc-2023-007340.

Reference Type DERIVED
PMID: 38309722 (View on PubMed)

Hwang M, Fan C, Yue MS, Zhou D, Paturel C, Andre P, Cheng LY, Mitchell P, Kourtesis P, Ruscica D, Das M, Morsli N, Ren S, Gibbs M, Phipps A, Song X. Population Pharmacokinetics of Monalizumab in Patients With Advanced Solid Tumors. J Clin Pharmacol. 2023 Jul;63(7):817-829. doi: 10.1002/jcph.2220. Epub 2023 Apr 10.

Reference Type DERIVED
PMID: 36852723 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D419NC00001&attachmentIdentifier=0025c0b0-10b2-4c30-a0be-d095e7e9d3a6&fileName=D419NC00001_Amd_6_Protocol_(1)-Redacted.pdf&versionIdentifier=

redacted CSP

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D419NC00001&attachmentIdentifier=d3f8249c-94ba-4dbd-b4a1-626d65c0860d&fileName=d419nc00001-sap-ed-2-Redacted.pdf&versionIdentifier=

redacted SAP

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D419NC00001&attachmentIdentifier=355cf93c-e8f1-452b-8fff-50f057aa7eee&fileName=D419NC00001_CSR_Synopsis_(21Sep22)-Redacted.pdf&versionIdentifier=

redacted CSR Synopsis

Other Identifiers

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D419NC00001

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2016-000662-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

D419NC00001

Identifier Type: -

Identifier Source: org_study_id

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