A Study of Durvalumab (MEDI4736) and IPH2201 in Solid Tumors - Full Text View

Purpose

This is a multicenter, open-label, dose-escalation and dose-expansion study to evaluate the safety, tolerability, antitumor activity, PK, pharmacodynamics, and immunogenicity of Durvalumab (MEDI4736) in combination with IPH2201 in Adult Subjects with selected advanced solid tumors.

Condition	Intervention	Phase
Advanced Solid Tumors	Drug: Intervention	Phase 1


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: No masking Primary Purpose: Treatment
Official Title:	A Phase 1 Study of Durvalumab and IPH2201 in Adult Subjects With Select Advanced Solid Tumors

Resource links provided by NLM:

Drug Information available for: Durvalumab

U.S. FDA Resources

Further study details as provided by MedImmune LLC:

Primary Outcome Measures:

Number of subjects reporting adverse events [ Time Frame: Screening through 90 days after the last dose of study medication ]
Number of subjects reporting serious adverse events [ Time Frame: Screening through 90 days after the last dose of study medication ]
Number of subjects experiencing dose-limiting toxicities [ Time Frame: First dose of study medications through 4 weeks after the first dose of study medication ]
Change from Baseline in laboratory evaluations [ Time Frame: Screening through 90 days after the last dose of study medication ] ]
Change from Baseline in electrocardiograms [ Time Frame: Screening through 90 days through last dose of study medication ]
Change from Baseline in vital signs [ Time Frame: Screening through 90 days after the last dose of study medication ]

Secondary Outcome Measures:

Objective Response Rate [ Time Frame: Time Frame: Screening through 5 years after the last subject receives the first dose of study medication ]
Disease Control Rate [ Time Frame: Screening through 5 years after the last subject receives the first dose of study medication ]
Duration of Response [ Time Frame: Screening through 5 years after the last subject receives the first dose of study medication ]
Individual Durvalumab concentrations [ Time Frame: First dose of Durvalumab through 3 months after the last dose of study medication ]
Individual IPH2201 Concentration [ Time Frame: First dose of IPH2201 through 3 months after the last dose of study medication ]
Durvalumab area under the concentration-curve [ Time Frame: First dose of Durvalumab through 3 months after the last dose of study medication ]
IPH2201 area under the concentration-curve [ Time Frame: First dose of IPH2201 through 3 months after the last dose of study medication ]
Number of subjects and percentage of subjects who develop detectable anti-drug antibodies [ Time Frame: First dose of Durvalumab through 3 months after the last dose of study medication ]
Progression Free Survival [ Time Frame: Screening through 5 years after the last subject receives the first dose of study medication ]
Overall Survival [ Time Frame: Screening through 5 years after the last subject receives the first dose of study medication ]


Estimated Enrollment:	175
Actual Study Start Date:	February 22, 2016
Estimated Study Completion Date:	August 30, 2019
Estimated Primary Completion Date:	August 30, 2019 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: treatment Arm Durvalumab and IPH2201	Drug: Intervention Biological: Durvalumab Biological: IPH2201

Detailed Description:

This is a Phase 1, multicenter, open-label, single-arm dose-escalation and dose-expansion study of durvalumab in combination with IPH2201 to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and antitumor activity in adult subjects with selected advanced solid tumors. The study consists of 2 parts: dose escalation and dose expansion.

Subjects will receive durvalumab and IPH2201 via 2 separate IV infusions. Subjects will receive durvalumab and IPH2201 until unacceptable toxicity, documentation of confirmed progressive disease (PD), or documentation of subject withdrawal for another reason.

Eligibility


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

Criteria

Inclusion Criteria:

Subjects must have histologic documentation of advanced recurrent or metastatic cancer.
Subjects must have received and have progressed or are refractory to at least one line of standard systemic therapy in the recurrent/metastatic setting, with selected advanced solid tumors.
Subjects must have at least one lesion that is measurable by RECIST v1.1 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 durvalumab and IPH2201 4. Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment. Concurrent use of hormones for non-cancer-related conditions is acceptable. Local treatment of isolated lesions for palliative intent is acceptable beyond the DLT-evaluation period with prior consultation and in agreement with the medical monitor. 5. Current or prior use of immunosuppressive medication within 14 days before the first dose.

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02671435

Contacts


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

Locations


United States, Arizona
Research Site	Recruiting
Scottsdale, Arizona, United States, 85258
United States, California
Research Site	Recruiting
La Jolla, California, United States, 92093-0987
United States, Colorado
Research Site	Recruiting
Aurora, Colorado, United States, 80045
United States, Florida
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, Michigan
Research Site	Recruiting
Detroit, Michigan, United States, 48202
United States, New York
Research Site	Recruiting
New York, New York, United States, 10065
United States, Texas
Research Site	Recruiting
San Antonio, Texas, United States, 78229
Canada, Ontario
Research Site	Recruiting
Toronto, Ontario, Canada, M5G 2M9
Hungary
Research Site	Recruiting
Budapest, Hungary, 1122
Research Site	Recruiting
Debrecen, Hungary, 4032
Italy
Research Site	Recruiting
Milano, Italy, 20132
Research Site	Recruiting
Milano, Italy, 20141
Spain
Research Site	Recruiting
Barcelona, Spain, 08035
Research Site	Recruiting
Madrid, Spain, 28034
Research Site	Recruiting
Sevilla, Spain, 41013

Sponsors and Collaborators

MedImmune LLC

More Information


Responsible Party:	MedImmune LLC
ClinicalTrials.gov Identifier:	NCT02671435 History of Changes
Other Study ID Numbers:	D419NC00001 D419NC00001 ( Other Grant/Funding Number: Medimmune LLC )
Study First Received:	January 28, 2016
Last Updated:	June 5, 2017

ClinicalTrials.gov processed this record on June 23, 2017