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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02671435
Recruitment Status : Recruiting
First Posted : February 2, 2016
Last Update Posted : January 15, 2020
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC

Brief 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).

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Combination Product: Intervention Phase 1 Phase 2

Detailed 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 subjects 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 subjects 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 subjects with CRC.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 381 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Study of Durvalumab and Monalizumab in Adult Subjects With Select Advanced Solid Tumors
Actual Study Start Date : February 22, 2016
Estimated Primary Completion Date : March 18, 2022
Estimated Study Completion Date : March 18, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Durvalumab

Arm Intervention/treatment
Experimental: Part 1 -Dose escalation with 5 dose escalation cohorts
Durvalumab and monalizumab
Combination Product: Intervention
Biological: Durvalumab Biological: Monalizumab Biological: Cetuximab

Experimental: Part 2 - Dose expansion with 4 dose expansion cohorts
Durvalumab with monalizumab
Combination Product: Intervention
Biological: Durvalumab Biological: Monalizumab Biological: Cetuximab

Experimental: Part 3 -Dose Exploration with 10 dose exploration cohorts.
Durvalumab and monalizumab and standard of standard of care systemic therapy with or without a biologic agent and monalizumab in combination with biologic agent in CRC.
Combination Product: Intervention
Biological: Durvalumab Biological: Monalizumab Biological: Cetuximab




Primary Outcome Measures :
  1. Occurrence of Drug Limited Toxicities (DLTs) [ Time Frame: From Time of First dose through DLT Screening period ]
    To assess by the occurrence of Drug Limited Toxicities (DLTs)

  2. Number of patients with changes in vital signs from baseline [ Time Frame: From time of screening through 90 days (+/- 7 days) after the last dose of study medication ]
    To assess safety of monalizumab +durva, or monalizumab+durva +standard of care systemic therapy with or without biological agent or monalizumab + with biological agent

  3. Occurrence of adverse events (AEs) [ Time Frame: From time of screening through 90 days (+/- 7 days) after the last dose of study medication ]
    To assess by the occurrence of adverse events (AEs)

  4. Number of patients with changes in electrocariogram (ECG) from baseline [ Time Frame: From time of screening through 90 days (+/- 7 days) after the last dose of study medication ]
    To assess safety of monalizumab +durva, or monalizumab+durva +standard of care systemic therapy with or without biological agent, or monalizumab + with biological agent

  5. Occurrence of serious adverse events (SAEs) [ Time Frame: From time of screening through 90 days (+/- 7 days) after the last dose of study medication ]
    To assess by the occurrence of serious adverse events (SAEs)

  6. Number of patients with changes in laboratory parameters from baseline [ Time Frame: From time of screening through 90 days (+/- 7 days) after the last dose of study medication ]
    To assess safety of monalizumab +durva, or monalizumab +durva +standard of care systemic therapy with or without biological agent, or monalizumab + with biological agent

  7. Objective Response Rate (ORR) [ Time Frame: From time of first dose of study medication through 5 years ]
    To assess anti-tumor activity of monalizumab + durva without biological agent, or monalizumab + with biological agent


Secondary Outcome Measures :
  1. Expression of pre-treatment protein within the tumor microenvironment [ Time Frame: From time of screening through 90 days (+/- 7 days) after the last dose of study medication ]
    To assess biomarker predicting activity of monalizumab+durva in combo with standard of care systemic therapy with or without biological agent, or monalizumab + with biological agent

  2. Number of subjects who develop anti-drug antibodies [ Time Frame: From time of first dose through 90 days (+/- 7 days) after the last dose of study medication ]
    To assess the immunogenicity of mona+durva with or without standard of care systemic therapy or biological agent, or monalizumab + with biological agent

  3. Durva, monalizumab, biologic agent serum peak concentration (cMax) concentration for Pharmacokinetics [ Time Frame: From time of first dose through 90 days (+/- 7 days) after the last dose of study medication ]
    To assess the pharmacokinetics of Durvalumab and monalizumab or monalizumab+durva +standard of care systemic therapy with or without biological agent, or monalizumab + with biological agent

  4. Durva and monalizumab serum area under the concentration-time curve (AUC) concentration for Pharmacokinetics [ Time Frame: From time of first dose through 90 days (+/- 7 days) after the last dose of study medication ]
    To assess the pharmacokinetics of Durvalumab and monalizumab or monalizumab+durva +standard of care systemic therapy with or without biological agent, monalizumab + with biological agent

  5. Durva and monalizumab serum clearance (CL) concentration for Pharmacokinetics [ Time Frame: From time of first dose through 90 days (+/- 7 days) after the last dose of study medication ]
    To assess the pharmacokinetics of Durvalumab and monalizumab or monalizumab+durva +standard of care systemic therapy with or without biological agent, or monalizumab + with biological agent

  6. Durva and monalizumab serum terminal elimination half-life (t1/2) concentration for Pharmacokinetics [ Time Frame: From first dose through 90 days (+/- 7 days) after the last dose of study medication ]
    To assess the pharmacokinetics of Durvalumab and monalizumab or monalizumab+durva +standard of care systemic therapy with or without biological agent, or monalizumab + with biological agent

  7. Objective Response Rate (ORR) [ Time Frame: From time of first dose of study medication through 5 years ]
    To assess anti-tumor activity of monalizumab +durva, or monalizumab+durva +standard of care systemic therapy with or without biological agent, or monalizumab + with biological agent

  8. Progression Free Survival (PFS) [ Time Frame: From time of first dose of study medication through 5 years ]
    To assess anti-tumor activity of monalizumab +durva, or monalizumab+durva +standard of care systemic therapy with or without biological agent, or monalizumab + with biological agent

  9. Disease Control Rate (DC) [ Time Frame: From time of first dose of study medication through 5 years ]
    To assess anti-tumor activity of monalizumab +durva, or monalizumab+durva +standard of care systemic therapy with or without biological agent, or monalizumab + with biological agent

  10. Overall Survival (OS) [ Time Frame: From time of first dose of study medication through 5 years ]
    To assess anti-tumor activity of monalizumab +durva, or monalizumab+durva +standard of care systemic therapy with or without biological agent, or monalizumab + with biological agent

  11. Duration of Response (DoR) [ Time Frame: From time of first dose of study medication through 5 years ]
    To assess anti-tumor activity of monalizumab +durva, or monalizumab+durva +standard of care systemic therapy with or without biological agent, or monalizumab + with biological agent



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02671435


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
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United States, Alabama
Research Site Not yet recruiting
Birmingham, Alabama, United States, 35233
United States, Arizona
Research Site Recruiting
Scottsdale, Arizona, United States, 85258
United States, California
Research Site Recruiting
Duarte, California, United States, 91010
Research Site Recruiting
La Jolla, California, United States, 92093
Research Site Recruiting
Long Beach, California, United States, 90806
Research Site Recruiting
Los Angeles, California, United States, 90033
Research Site Not yet recruiting
Newport Beach, California, United States, 92663
Research Site Recruiting
Sacramento, California, United States, 95817
Research Site Recruiting
Santa Monica, California, United States, 90404
United States, Colorado
Research Site Recruiting
Aurora, Colorado, United States, 80045
United States, Florida
Research Site Not yet recruiting
Gainesville, Florida, United States, 32608
Research Site Recruiting
Tampa, Florida, United States, 33612
United States, Illinois
Research Site Recruiting
Chicago, Illinois, United States, 60611
United States, Maryland
Research Site Recruiting
Baltimore, Maryland, United States, 21231
United States, Massachusetts
Research Site Recruiting
Boston, Massachusetts, United States, 02215
United States, Michigan
Research Site Recruiting
Detroit, Michigan, United States, 48202
United States, New Jersey
Research Site Recruiting
New Brunswick, New Jersey, United States, 08903
United States, New York
Research Site Recruiting
Bronx, New York, United States, 10461
Research Site Recruiting
Lake Success, New York, United States, 11042
Research Site Recruiting
New York, New York, United States, 10065
United States, Pennsylvania
Research Site Recruiting
Philadelphia, Pennsylvania, United States, 19107
United States, Rhode Island
Research Site Recruiting
Providence, Rhode Island, United States, 02903
Research Site Withdrawn
Providence, Rhode Island, United States, 02906
United States, Tennessee
Research Site Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
Research Site Recruiting
Dallas, Texas, United States, 75235
Research Site Not yet recruiting
Dallas, Texas, United States, 75235
Research Site Recruiting
San Antonio, Texas, United States, 78229
United States, Utah
Research Site Recruiting
Salt Lake City, Utah, United States, 84112
United States, Washington
Research Site Not yet recruiting
Seattle, Washington, United States, 98109
Australia
Research Site Recruiting
Blacktown, Australia, 2148
Research Site Recruiting
Clayton, Australia, 3168
Research Site Not yet recruiting
St Leonards, Australia, 2065
Research Site Recruiting
Waratah, Australia, 2298
Belgium
Research Site Recruiting
Bruxelles, Belgium, 1200
Research Site Recruiting
Edegem, Belgium, 2650
Research Site Recruiting
Gent, Belgium, 9000
Research Site Recruiting
Leuven, Belgium, 3000
Brazil
Research Site Not yet recruiting
Barretos, Brazil, 14784-400
Research Site Not yet recruiting
Caxias do Sul, Brazil, 95070-560
Research Site Not yet recruiting
Porto Alegre, Brazil, 90619-900
Research Site Not yet recruiting
Porto Alegre, Brazil, 91350-200
Research Site Not yet recruiting
Rio de Janeiro, Brazil, 20231-050
Research Site Not yet recruiting
Sao Jose Rio Preto, Brazil, 15090-000
Research Site Withdrawn
Sao Paulo, Brazil, 01246-000
Research Site Not yet recruiting
Sao Paulo, Brazil, 01308-050
Research Site Not yet recruiting
Sao Paulo, Brazil, 04532-030
Canada, British Columbia
Research Site Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
Research Site Not yet recruiting
Toronto, Ontario, Canada, M4N 3M5
Research Site Recruiting
Toronto, Ontario, Canada, M5G 2M9
Canada
Research Site Recruiting
Quebec, Canada, G1R 2J6
France
Research Site Recruiting
Marseille CEDEX 5, France, 13385
Research Site Recruiting
Nantes CEDEX 1, France, 44093
Research Site Not yet recruiting
Villejuif, France, 94805
Hungary
Research Site Withdrawn
Budapest, Hungary, 1122
Research Site Not yet recruiting
Budapest, Hungary, 1134
Research Site Recruiting
Debrecen, Hungary, 4032
Italy
Research Site Recruiting
Milano, Italy, 20132
Research Site Recruiting
Milano, Italy, 20141
Korea, Republic of
Research Site Recruiting
Seongnam-si, Korea, Republic of, 13620
Research Site Recruiting
Seoul, Korea, Republic of, 03080
Research Site Recruiting
Seoul, Korea, Republic of, 03722
Research Site Recruiting
Seoul, Korea, Republic of, 05505
Research Site Recruiting
Seoul, Korea, Republic of, 06351
Research Site Recruiting
Seoul, Korea, Republic of, 06591
New Zealand
Research Site Recruiting
Grafton, New Zealand, 1023
Spain
Research Site Recruiting
Barcelona, Spain, 08035
Research Site Recruiting
Madrid, Spain, 28027
Research Site Recruiting
Madrid, Spain, 28034
Research Site Recruiting
Málaga, Spain, 29010
Research Site Recruiting
Pamplona, Spain, 31008
Research Site Recruiting
Sevilla, Spain, 41013
United Kingdom
Research Site Recruiting
London, United Kingdom, SW2 6JJ
Research Site Recruiting
Sutton, United Kingdom, SM2 5PT
Sponsors and Collaborators
MedImmune LLC

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Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT02671435    
Other Study ID Numbers: D419NC00001
D419NC00001 ( Other Grant/Funding Number: Medimmune LLC )
First Posted: February 2, 2016    Key Record Dates
Last Update Posted: January 15, 2020
Last Verified: January 2020
Keywords provided by MedImmune LLC:
Colorectal, colon, CRC, solid tumors, check point inhibitors, immunotherapy, metastatic
Additional relevant MeSH terms:
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Neoplasms
Durvalumab
Antibodies, Monoclonal
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs