Colon Cancer Clinical Trial

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

Summary

This is a multicenter, open-label, dose-escalation, dose-exploration and dose-expansion study to evaluate the safety, tolerability, antitumor activity, PK, pharmacodynamics, and immunogenicity of Durvalumab (MEDI4736) in combination with monalizumab (IPH2201) in Adult Subjects 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 subjects with recurrent or metastatic colorectal cancer (CRC).

View Full Description

Full Description

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.

View Eligibility Criteria

Eligibility Criteria

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.

Study is for people with:

Colon Cancer

Phase:

Phase 1

Estimated Enrollment:

383

Study ID:

NCT02671435

Recruitment Status:

Active, not recruiting

Sponsor:

MedImmune LLC

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There are 49 Locations for this study

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Research Site
Birmingham Alabama, 35233, United States
Research Site
Scottsdale Arizona, 85258, United States
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Duarte California, 91010, United States
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La Jolla California, 92093, United States
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Los Angeles California, 90089, United States
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Sacramento California, 95817, United States
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Santa Monica California, 90404, United States
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Aurora Colorado, 80045, United States
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Tampa Florida, 33612, United States
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Chicago Illinois, 60611, United States
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Baltimore Maryland, 21231, United States
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Boston Massachusetts, 02215, United States
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Detroit Michigan, 48202, United States
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New Brunswick New Jersey, 08903, United States
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Bronx New York, 10461, United States
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New Hyde Park New York, 11042, United States
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New York New York, 10065, United States
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Providence Rhode Island, 02903, United States
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Nashville Tennessee, 37203, United States
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Dallas Texas, 75235, United States
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San Antonio Texas, 78229, United States
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Salt Lake City Utah, 84112, United States
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Blacktown , 2148, Australia
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Clayton , 3168, Australia
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Waratah , 2298, Australia
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Bruxelles , 1200, Belgium
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Edegem , 2650, Belgium
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Leuven , 3000, Belgium
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Vancouver British Columbia, V5Z 4, Canada
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Toronto Ontario, M5G 1, Canada
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Marseille CEDEX 5 , 13385, France
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Nantes CEDEX 1 , 44093, France
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Debrecen , 4032, Hungary
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Milano , 20132, Italy
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Milano , 20141, Italy
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Seoul , 03080, Korea, Republic of
Research Site
Seoul , 03722, Korea, Republic of
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Seoul , 05505, Korea, Republic of
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Seoul , 06351, Korea, Republic of
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Seoul , 06591, Korea, Republic of
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Grafton , 1023, New Zealand
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Barcelona , 08035, Spain
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Madrid , 28027, Spain
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Madrid , 28034, Spain
Research Site
Málaga , 29010, Spain
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Pamplona , 31008, Spain
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Sevilla , 41013, Spain
Research Site
London , SW2 6, United Kingdom
Research Site
Sutton , SM2 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Phase:

Phase 1

Estimated Enrollment:

383

Study ID:

NCT02671435

Recruitment Status:

Active, not recruiting

Sponsor:


MedImmune LLC

How clear is this clinincal trial information?

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