A Study of Durvalumab (MEDI4736) and IPH2201 in Solid Tumors
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Advanced Solid Tumors | Drug: Intervention | Phase 1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | A Phase 1 Study of Durvalumab and IPH2201 in Adult Subjects With Select Advanced Solid Tumors |
- 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 ]
- 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: | 208 |
| Actual Study Start Date: | February 22, 2016 |
| Estimated Study Completion Date: | October 30, 2019 |
| Estimated Primary Completion Date: | October 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
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.
| Ages Eligible for Study: | 18 Years to 99 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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
| Contact: AstraZeneca Clinical Study Information Center | 1-877-240-9479 | information.center@astrazeneca.com |
| United States, Arizona | |
| Research Site | Recruiting |
| Scottsdale, Arizona, United States, 85258 | |
| United States, California | |
| Research Site | Recruiting |
| La Jolla, California, United States, 92093 | |
| 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 |
| Málaga, Spain, 29010 | |
| Research Site | Recruiting |
| Sevilla, Spain, 41013 | |
| United Kingdom | |
| Research Site | Recruiting |
| London, United Kingdom, SW2 6JJ | |
| Research Site | Recruiting |
| Sutton, United Kingdom, SM2 5PT | |
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 ) |
| First Submitted: | January 28, 2016 |
| First Posted: | February 2, 2016 |
| Last Update Posted: | October 5, 2017 |
| Last Verified: | September 2017 |