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Completed

NCT Number: NCT02261220

A Phase 1 Study of MEDI4736 in Combination With Tremelimumab in Subjects With Advanced Solid Tumors

This is a multicenter, open-label, dose-exploration and dose-expansion study to evaluate the safety, tolerability, antitumor activity, PK and immunogenicity of MEDI4736 in combination with tremelimumab in subjects with select advanced solid tumors.

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Key information

Conditions

Advanced Solid Tumors

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, London, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female subjects
  • 18 years and older
  • Histologic confirmation of advanced solid tumors
  • Subjects must have recurrent/metastatic disease and may have been previously treated in the recurrent/metastatic setting.

Exclusion criteria

  • Any concurrent chemotherapy, immune-mediated therapy or biologic or hormonal therapy for cancer treatment
  • Active or prior documented autoimmune disease within the past 2 years
  • Current or prior use of immunosuppressive medication within 14 days with some exceptions.

Treatment and study plan

MEDI4736

Biological

MEDI4736 is administered by IV infusion in combination with tremelimumab

Tremelimumab

Biological

Tremelimumab is administered by IV infusion in combination with MEDI4736

Primary outcomes

  1. Number of subjects reporting adverse events

    Time frame: Screening through 15 months after the last subject enters re-treatment

  2. Number of subjects reporting serious adverse events

    Time frame: Screening through 15 months after the last subject enters re-treatment

  3. Number of subjects experiencing a dose-limiting toxicity

    Time frame: First dose of study medication through 4 weeks after the first dose of study medication

  4. Change from Baseline in laboratory evaluations

    Time frame: Screening through 3 months after the last dose of study medication

  5. Change from Baseline in vital signs

    Time frame: Screening through 3 months after the last dose of study medication

  6. Change from Baseline in electrocardiogram evaluations

    Time frame: Screening through 3 months after the last dose of study medication

  7. Overall Response Rate in Select Tumor Types

    Time frame: First dose of study medication through 15 months after the last subject enters re-treatment

Secondary outcomes

  1. Overall Response Rate

    Time frame: First dose of study medication through 15 months after the last subject enters re-treatment

  2. Disease Control Rate

    Time frame: First dose of study medication through 15 months after the last subject enters re-treatment

  3. Duration of Response

    Time frame: First dose of study medication through 15 months after the last subject enters re-treatment

  4. Progression-Free Survival

    Time frame: First dose of study medication through 15 months after the last subject enters re-treatment

  5. Overall Survival

    Time frame: First dose of study medication through 15 months after the last subject enters re-treatment

  6. Individual MEDI4736 concentrations

    Time frame: First dose of MEDI4736 through 3 months after the last dose of study medication

  7. Individual tremelimumab concentrations

    Time frame: First dose of tremelimumab through 3 months after the last dose of study medication

  8. MEDI4736 area under the concentration-curve

    Time frame: First dose of MEDI4736 through 3 months after the last dose of study medication

  9. Tremelimumab area under the concentration-curve

    Time frame: First dose of tremelimumab through 3 months after the last dose of study medication

  10. Number of subjects that develop detectable antidrug antibodies to MEDI4736

    Time frame: First dose of MEDI4736 through 3 months after the last dose of study medication

  11. Number of subjects that develop antidrug antibodies to tremelimumab

    Time frame: First dose of tremelimumab through 3 months after the last dose of study medication

Other outcomes

  1. Change in Biomarkers

    Time frame: Screening through 3 months following the last dose of study medication

Sponsors and collaborators

Lead sponsor

MedImmune LLC

Industry

Registry information

Official study title

A Phase I Study of MEDI4736 (Anti-PD-L1 Antibody) in Combination With Tremelimumab (Anti-CTLA-4 Antibody) in Subjects With Advanced Solid Tumors

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Oct 10, 2014
Registry last updated
Mar 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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