Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 3 for:    MEDI0680

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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02118337
Recruitment Status : Completed
First Posted : April 21, 2014
Last Update Posted : April 14, 2020
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC

Brief Summary:
To evaluate the Safety and Antitumor Activity of MEDI0680 (AMP-514) in Combination with Durvalumab versus Nivolumab Monotherapy in Subjects with Select Advanced Malignancies.

Condition or disease Intervention/treatment Phase
Select Advanced Malignancies Kidney Cancer Clear Cell Renal Cell Carcinoma Biological: MEDI0680 Biological: Durvalumab Biological: Nivolumab Phase 1 Phase 2

Detailed Description:
This is a multicenter, open-label, Phase 1/2 study to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of MEDI0680 in combination with durvalumab or nivolumab monotherapy in adult immunotherapy-naïve subjects with selected advanced malignancies.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 19, 2014
Actual Primary Completion Date : March 17, 2020
Actual Study Completion Date : March 17, 2020


Arm Intervention/treatment
Experimental: 0.1 mg/kg MEDI0680 Q2W; 3 mg/kg durvalumab Q2W
MEDI0680 and Durvalumab in combination
Biological: MEDI0680
anti-PD-1

Biological: Durvalumab
anti-PD-L1

Active Comparator: Nivolumab
Nivolumab monotherapy at the selected dose
Biological: Nivolumab
anti PD-1

Experimental: 0.5 mg/kg MEDI0680 Q2W; 10 mg/kg durvalumab Q2W
MEDI0680 and Durvalumab combination
Biological: MEDI0680
anti-PD-1

Biological: Durvalumab
anti-PD-L1

Experimental: 0.1 mg/kg MEDI0680 Q2W; 10 mg/kg durvalumab Q2W
MEDI0680 and Durvalumab in combination
Biological: MEDI0680
anti-PD-1

Biological: Durvalumab
anti-PD-L1

Experimental: 2.5 mg/kg MEDI0680 Q2W; 10 mg/kg durvalumab Q2W
MEDI0680 and Durvalumab in combination
Biological: MEDI0680
anti-PD-1

Biological: Durvalumab
anti-PD-L1

Experimental: 10 mg/kg MEDI0680 Q2W; 10 mg/kg durvalumab Q2W
MEDI0680 and Durvalumab in combination
Biological: MEDI0680
anti-PD-1

Biological: Durvalumab
anti-PD-L1

Experimental: 20 mg/kg MEDI0680 Q2W; 10 mg/kg durvalumab Q2W
MEDI0680 and Durvalumab in combination
Biological: MEDI0680
anti-PD-1

Biological: Durvalumab
anti-PD-L1

Experimental: 20 mg/kg MEDI0680 Q2W; 750 mg durvalumab Q2W
MEDI0680 and Durvalumab in combination
Biological: MEDI0680
anti-PD-1




Primary Outcome Measures :
  1. Dose Escalation: Number of subjects with adverse events [ Time Frame: From first dose of study drugs until 90 days after the last dose of study drugs ]
    Assessed by number of subjects with AEs and SAEs

  2. Dose Expansion: Antitumor activity [ Time Frame: From first dose of study drug through study completion ]
    Determination of antitumor activity based on investigator assessed response using RECIST v1.1


Secondary Outcome Measures :
  1. Dose Escalation: Antitumor activity of MEDI0680 in combination with MEDI4736 in subjects with select advanced malignancies [ Time Frame: From first dose of study drugs through study completion ]
    Determination of antitumor activity based on investigator assessed response using RECIST v1.1

  2. Dose Expansion: Safety of MEDI0680 Monotherapy and in combination with MEDI4736 [ Time Frame: From first dose through 90 days after last dose of study drugs ]
    To be assessed by number of subjects with AEs and SAEs

  3. Dose Expansion: Antitumor activity of MEDI0680 monotherapy and in combination with MEDI4736 [ Time Frame: From the time of first dose through study completion ]
    Determination of antitumor activity based on blinded independent central review assessed response using RECIST v1.1

  4. Both Phases: Pharmacokinetics of MEDI0680 monotherapy and in combination with MEDI4736 and MEDI4736 in combination with MEDI0680 [ Time Frame: From first dose until 12 months after the last dose ]
    Pharmacokinetics as measured by drug concentration in serum

  5. Both Phases: Immunogenicity of MEDI0680 and MEDI4736 [ Time Frame: From first dose of study drugs until 12 months after last dose of study drugs ]
    Immunogenicity as measured by presence of detectable ADAs

  6. PD-L1 as a predictive biomarker [ Time Frame: From first dose of study drug through study completion ]
    PD-L1 expression on the tumor membrane and tumor-infiltrating immune cells within the tumor microenvironment



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 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

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): NCT02118337


Locations
Layout table for location information
United States, California
Research Site
Los Angeles, California, United States, 90025
United States, Florida
Research Site
Tampa, Florida, United States, 33612
United States, Kansas
Research Site
Overland Park, Kansas, United States, 66209
United States, Kentucky
Research Site
Louisville, Kentucky, United States, 40202
United States, Minnesota
Research Site
Rochester, Minnesota, United States, 55905
United States, New Jersey
Research Site
Hackensack, New Jersey, United States, 07601
United States, New York
Research Site
New York, New York, United States, 10065
United States, Ohio
Research Site
Cleveland, Ohio, United States, 44195
United States, Oklahoma
Research Site
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Research Site
Portland, Oregon, United States, 97213
United States, Pennsylvania
Research Site
Hershey, Pennsylvania, United States, 17033-0850
United States, Tennessee
Research Site
Nashville, Tennessee, United States, 37203
United States, Washington
Research Site
Seattle, Washington, United States, 98109
Australia
Research Site
East Bentleigh, Australia, 3165
Research Site
Frankston, Australia, 3199
Canada, Ontario
Research Site
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Research Site
Montreal, Quebec, Canada, H3T 1E2
France
Research Site
Bordeaux, France, 33075
Research Site
Dijon, France, 21079
Research Site
Marseille, France, 13009
Research Site
Paris Cedex 15, France, 75908
Research Site
Villejuif, France, 94805
Netherlands
Research Site
Amsterdam, Netherlands, 1066 CX
Research Site
Groningen, Netherlands, 9713 GZ
United Kingdom
Research Site
Cambridge, United Kingdom, CB2 0QQ
Research Site
Cardiff, United Kingdom, CF14 2TL
Research Site
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
MedImmune LLC
Investigators
Layout table for investigator information
Principal Investigator: Laura Chow, MD University of Washington
Principal Investigator: Omid Hamid, MD The Angeles Clinic
Principal Investigator: Jhanelle Gray, MD Moffitt Cancer Center
Principal Investigator: Rachel Sanborn, MD Providence Cancer Center
Principal Investigator: Mohamad Salkeni, MD Mary Babb Randolph Cancer Center
Principal Investigator: Monika Joshi, MD Penn State Hershey Cancer Institute
Principal Investigator: Robert Alter, MD John Theurer Cancer Center
Principal Investigator: Raid Aljumaily, MD Peggy Charles Stephenson Cancer Center
Principal Investigator: Jason Chesney, MD Brown Cancer Center
Principal Investigator: Fernando Quevedo, MD Mayo Clinic
Principal Investigator: Martin Voss, MD Memorial Sloan Kettering Cancer Center
Principal Investigator: Johanna Bendell SCRI Development Innovations, LLC
Principal Investigator: Elizabeth Henry Loyola Univ. Medical Center
Principal Investigator: Lionel Lewis Dartmouth-Hitchcock Medical Center
Principal Investigator: Brian Rini The Cleveland Clinic
Principal Investigator: Peter Van Veldhuizen Menorah Medical Center tour
Layout table for additonal information
Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT02118337    
Other Study ID Numbers: D6020C00001
First Posted: April 21, 2014    Key Record Dates
Last Update Posted: April 14, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home
Keywords provided by MedImmune LLC:
select advanced malignancies,
kidney cancer,
clear cell renal cell carcinoma
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Nivolumab
Durvalumab
Antineoplastic Agents, Immunological
Antineoplastic Agents