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Trial record 1 of 1 for:    d419nc00001
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A Study of Durvalumab (MEDI4736) and IPH2201 in Solid Tumors

This study is currently recruiting participants.
Verified November 2017 by MedImmune LLC
Sponsor:
ClinicalTrials.gov Identifier:
NCT02671435
First Posted: February 2, 2016
Last Update Posted: November 9, 2017
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.
Information provided by (Responsible Party):
MedImmune LLC
  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: None (Open Label)
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:


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: 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

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.


Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
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 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.
  3. 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
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
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

  Show 22 Study Locations
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 )
First Submitted: January 28, 2016
First Posted: February 2, 2016
Last Update Posted: November 9, 2017
Last Verified: November 2017