A clinical trial in patients with renal cell cancer that have had at least one, but no more than three prior cancer treatments and their cancer has gotten worse or did not respond. The study is investigating the safety, tolerability, and clinical activity of investigational drugs MEDI0680 and Durvalumab. The study will look at the effect of these two drugs when given to patients in combination (given together) versus nivolumab given alone.

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

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000323-43-GB

Enrollment

Registered

2016-09-09

Start date

2017-10-31

Completion date

Unknown

Last updated

2020-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

clear-cell renal cell carcinoma MedDRA version: 20.0 Level: LLT Classification code 10038407 Term: Renal cell cancer System Organ Class: 100000072939

Interventions

Product Name: MEDI0680 Product Code: MEDI0680 Pharmaceutical Form: Solution for infusion INN or Proposed INN: Not assigned CAS Number: 1607465-69-9 Current Sponsor code: MEDI0680 Other descriptive nam

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Must be 18 years or older -Eastern Cooperative Oncology Group performance status of 0-1 -Adequate organ function -No more than 1 prior line of therapy For complete list of inclusion criteria please refer to the protocol Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 36 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60

Exclusion criteria

Exclusion criteria: -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 For complete list of exclusion criteria please refer to the protocol

Design outcomes

Primary

Measure	Time frame
Main Objective: Dose-escalation: To determine the maximum tolerated dose (MTD) or the highest protocol-defined dose in the absence of exceeding the MTD for MEDI0680 in combination with durvalumab and the safety profile of MEDI0680 in combination with durvalumab in subjects with advanced malignancies Dose-expansion: To evaluate the objective response rate of MEDI0680 in combination with durvalumab versus nivolumab monotherapy in immunotherapy-naïve subjects with advanced or metastatic ccRCC as based on investigator assessed response using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;Secondary Objective: Dose-escalation: Evaluate the objective response rate of MEDI0680 in combination with durvalumab in subjects with advanced malignancies as based on the investigator assessed response using modified RECIST v1.1 Dose-expansion: Describe the safety and tolerability of MEDI0680 in combination with durvalumab or nivolumab monotherapy in immunotherapy-naïve subjects with advanced or metastatic ccRCC Evaluate the objective response rate of MEDI0680 in combination with durvalumab versus nivolumab monotherapy in immunotherapy-naïve subjects with advanced or metastatic ccRCC as based on blinded independent central review (BICR) assessed response using RECIST v1.1 Dose-escalation and Dose-expansion: 1. Describe the pharmacokinetics (PK) of MEDI0680 in combination with durvalumab 2. Determine the immunogenicity of MEDI0680 in combination with durvalumab 3. Determine whether PD-L1 is a predictive biomarker for response to therapy with MEDI0680 in combination with durvalumab;Primary end point(s): Dose Escalation: Safety assessment will include adverse events and serious adverse events as well as changes from baseline in lab parameters, vital signs, physical examination, and ECG results Dose Expansion: Antitumor activity assessment will be based on an application of RECIST v1.1 to investigator-assessed tumor measurements;Timepoint(s) of evaluation of this end	—

Measure

Time frame

Main Objective: Dose-escalation: To determine the maximum tolerated dose (MTD) or the highest protocol-defined dose in the absence of exceeding the MTD for MEDI0680 in combination with durvalumab and the safety profile of MEDI0680 in combination with durvalumab in subjects with advanced malignancies Dose-expansion: To evaluate the objective response rate of MEDI0680 in combination with durvalumab versus nivolumab monotherapy in immunotherapy-naïve subjects with advanced or metastatic ccRCC as based on investigator assessed response using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;Secondary Objective: Dose-escalation: Evaluate the objective response rate of MEDI0680 in combination with durvalumab in subjects with advanced malignancies as based on the investigator assessed response using modified RECIST v1.1 Dose-expansion: Describe the safety and tolerability of MEDI0680 in combination with durvalumab or nivolumab monotherapy in immunotherapy-naïve subjects with advanced or metastatic ccRCC Evaluate the objective response rate of MEDI0680 in combination with durvalumab versus nivolumab monotherapy in immunotherapy-naïve subjects with advanced or metastatic ccRCC as based on blinded independent central review (BICR) assessed response using RECIST v1.1 Dose-escalation and Dose-expansion: 1. Describe the pharmacokinetics (PK) of MEDI0680 in combination with durvalumab 2. Determine the immunogenicity of MEDI0680 in combination with durvalumab 3. Determine whether PD-L1 is a predictive biomarker for response to therapy with MEDI0680 in combination with durvalumab;Primary end point(s): Dose Escalation: Safety assessment will include adverse events and serious adverse events as well as changes from baseline in lab parameters, vital signs, physical examination, and ECG results Dose Expansion: Antitumor activity assessment will be based on an application of RECIST v1.1 to investigator-assessed tumor measurements;Timepoint(s) of evaluation of this end

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Secondary

Measure	Time frame
Secondary end point(s): Dose Escalation: 1. Antitumor activity of MEDI0680 in combination with MEDI4736 in subjects with advanced malignancies using modified RECIST v1.1 Dose Expansion: 2. Safety of MEDI0680 in combination with MEDI4736 3. Antitumor activity of MEDI0680 in combination with MEDI4736 4. Both Phases: Pharmacokinetics of MEDI0680 in combination with MEDI4736 5. Both Phases: Immunogenicity of MEDI0680 and MEDI4736 6. PD-L1 as a predictive biomarker;Timepoint(s) of evaluation of this end point: 1. From the first dose of study drugs through study completion 2. From First dose of study drugs to 90 days after the last dose of study drug administration 3. From the first dose of study drugs through study completion 4. From the first dose of study drugs through 12 months after the last dose of study drugs 5. From the first dose of study drugs through 12 months after the last dose of study drugs 6. From the first dose of study drugs through study completion	—

Measure

Time frame

Secondary end point(s): Dose Escalation: 1. Antitumor activity of MEDI0680 in combination with MEDI4736 in subjects with advanced malignancies using modified RECIST v1.1 Dose Expansion: 2. Safety of MEDI0680 in combination with MEDI4736 3. Antitumor activity of MEDI0680 in combination with MEDI4736 4. Both Phases: Pharmacokinetics of MEDI0680 in combination with MEDI4736 5. Both Phases: Immunogenicity of MEDI0680 and MEDI4736 6. PD-L1 as a predictive biomarker;Timepoint(s) of evaluation of this end point: 1. From the first dose of study drugs through study completion 2. From First dose of study drugs to 90 days after the last dose of study drug administration 3. From the first dose of study drugs through study completion 4. From the first dose of study drugs through 12 months after the last dose of study drugs 5. From the first dose of study drugs through 12 months after the last dose of study drugs 6. From the first dose of study drugs through study completion

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Countries

Australia, Canada, France, Korea, Republic of, Netherlands, United Kingdom, United States

Contacts

Public ContactAstraZeneca Study Info Center

MedImmune, LLC, a wholly-owned subsidiary of AstraZeneca PLC

information.center@astrazeneca.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026