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Closed (no longer recruiting)Last updated: 24 January 2024

AMP-514: This phase I/II trial is assessing the safety of the drug MEDI0680, given alone and in combination with MEDI4736 for patients with advanced cancerA Phase 1/2, Open-label Study to Evaluate the Safety and Antitumor Activity of MEDI0680 (AMP-514) in Combination With MEDI4736 and MEDI0680 Monotherapy in Subjects With Select Advanced Malignancies

Clinical summary

Summary

To evaluate the safety, tolerability and antitumor activity of MEDI0680 (AMP-514) given in combination with MEDI4736 and MEDI0680 monotherapy. This is a multicenter, open-label, dose-escalation, and dose expansion study of MEDI0680 given alone and in combination with MEDI4736 to evaluate the safety, tolerability, pharmacokinetic (PK), immunogenicity, and antitumor activity in adult subjects with select advanced malignancies.

Conditions

This trial is treating patients with select advanced cancers.

Cancer

Urinary System Cancers Genitourinary

Age

People18+

Phase

I/II

Trial Acronym

AMP-514

More information

Trial Identifiers

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Trial sponsor

MedImmune, LLC

Scientific Title

A Phase 1/2, Open-label Study to Evaluate the Safety and Antitumor Activity of MEDI0680 (AMP-514) in Combination With MEDI4736 and MEDI0680 Monotherapy in Subjects With Select Advanced Malignancies

Eligibility

Inclusion

  • Must be 18 years or older
  • Eastern Cooperative Oncology Group performance status of 0-1
  • Adequate organ function
  • At least 1 prior line of therapy

Exclusion

  • Concurrent enrollment in another clinical study, unless in follow-up period or it is an observational study
  • Concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment
  • Prior treatment with immunotherapy

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

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