A Study to Evaluate MEDI5752 and Axitinib in Subjects With Advanced Renal Cell Carcinoma
A Phase 1b, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of MEDI5752 in Combination With Axitinib in Subjects With Advanced Renal Cell Carcinoma
3 other identifiers
interventional
67
4 countries
20
Brief Summary
The purpose of this study is to evaluate MEDI5752 in combination with Lenvatinib (or Axitinib), in subjects with advanced renal cell carcinoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2020
Longer than P75 for phase_1
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2020
CompletedStudy Start
First participant enrolled
August 5, 2020
CompletedFirst Posted
Study publicly available on registry
August 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 26, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 26, 2025
CompletedJuly 25, 2025
July 1, 2025
5.1 years
July 22, 2020
July 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Number of subjects experiencing adverse events (AEs)/serious adverse events (SAEs)
The primary safety endpoint is as assessed by the number of subjects with adverse events and serious adverse events (SAEs) graded per NCI CTCAE v5.0.
Informed consent through 90-Day Post Last Dose.
Number of Participants With Dose Limiting Toxicities (DLT) of MEDI5752 and Lenvatinib (or Axitinib) during the Dose Exploration period.
Determine the MTD and recommended Phase 2 dose (RP2D) of the combination of MEDI5752 and Lenvatinib. A dose limiting toxicity (DLT) is defined as MEDI5752 treatment-related AE of any Grade 3 or higher toxicity (as defined in the protocol) CTCAE v5.0.
Informed consent through the first 21 days of treatment with MEDI5752 and Lenvatinib (or Axitinib) in the Dose Exploration Period.
Number of subjects experiencing adverse events (AEs) leading to discontinuation.
The primary safety endpoint is as assessed by the number of subjects with serious adverse events (SAEs) graded per NCI CTCAE v5.0.
Informed consent through 90-Day Post Last Dose.
Number of subjects experiencing abnormal laboratory evaluations.
The primary safety endpoint is as assessed by the number of subjects experiencing changes in laboratory evaluations from baseline.
Informed Consent through 90 post treatment date.
Number of subjects experiencing changes in vital signs reported as Adverse Events.
The primary safety endpoint is assessed by the change in vital signs from baseline.
Informed consent through 90-Day Post Last Dose
Number of subjects experiencing abnormal electrocardiograms (ECG) reported as Adverse Events.
The primary safety endpoint is as assessed by the change in ECG parameters from baseline.
Informed consent through 90-Day Post Last Dose
Preliminary antitumor activity of MEDI5752 combined with Lenvatinib (or Axitinib) by Objective response rate per RECIST version (v) 1.1.
The primary efficacy endpoint is assessed by the antitumor activity of MEDI5752 combined with Lenvatinib.
First subject enrolled through 18 months from last subject enrolled, an average of 30 months.
Secondary Outcomes (11)
Antitumor activity of MEDI5752 combined with Lenvatinib by measuring the progression free survival (PFS) according to RECIST v1.1.
Last Subject Enrolled through study completion, an average of 48 months.
Antitumor activity of MEDI5752 combined with Lenvatinib by measuring the Best Overall Response (BOR) according to RECIST v1.1.
First subject enrolled through 18 months from last subject enrolled, an average of 30 months.
Antitumor activity of MEDI5752 combined with Lenvatinib by measuring the Disease Control Rate (DCR).
Informed Consent through the date of first documented progression, end of study, date of death, or two years after last subject starts treatment whichever should occur first
Antitumor activity of MEDI5752 combined with Lenvatinib by measuring the Duration of Response (DOR) according to RECIST v1.1.
Informed Consent through the date of first documented progression, end of study, date of death, or two years after last subject starts treatment whichever should occur first
Antitumor activity of MEDI5752 combined with Lenvatinib by measuring the Time to Response (TTR) according to RECIST v1.1.
Informed Consent through the date of first documented progression, end of study, date of death, or two years after last subject starts treatment whichever should occur first
- +6 more secondary outcomes
Study Arms (2)
Dose Exploration
EXPERIMENTALThe Dose exploration Phase is made up of Part A, B and Part C. Part A will evaluate the safety and tolerability of MEDI5752 in combination with Axitinib (2 patients), and Part B and C will evaluate the safety and tolerability of MEDI5752 in combination with Lenvatinib (\~72 patients)
Dose Expansion
EXPERIMENTALEvaluate safety and anti-tumor activity of MEDI5752 in combination with Lenvatinib (\~105 patients )
Interventions
Eligibility Criteria
You may qualify if:
- Age ≥ 18 at the time of screening
- Body weight \> 35 kg
- Written informed consent
- Histologically or cytologically proven advanced RCC with clear cell component
- Advanced RCC not previously treated in that setting
- Provision of tumor material (≥ 5 unstained slides or tissue block) from an archival or fresh tissue sample
- ECOG performance status of 0 or 1
- Subjects must have at least 1 measurable lesion according to RECIST v1.1
- Life expectancy ≥ 12 weeks
- Adequate organ and marrow function
- Female subjects of childbearing potential must have negative pregnancy test at screening and prior to each administration of investigational product, and must use at least one highly effective method of contraception.
- Strongly recommend nonsterilized male partners of female subjects of childbearing potential use a male condom plus spermicide from screening to 7.6 months after the last dose of MEDI5752 and 30 days after the last dose of lenvatinib.
You may not qualify if:
- Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results
- Concurrent enrollment in another clinical study, unless it is an observational study.
- Previous treatment with mTOR inhibitors, PD-1, PD-L1, or CTLA-4 inhibitors for RCC or any other immune checkpoint inhibitor
- Previous treatment with VEGF inhibitors
- Evidence of the following infections: active infection including tuberculosis, human immunodeficiency virus, chronic or active hepatitis B or chronic or active hepatitis C
- History of organ transplant
- Active or prior documented autoimmune or inflammatory disorders
- Current or prior use of immunosuppressive medication within 14 days prior to the first dose of investigational product.
- Poorly controlled blood pressure (BP) defined as systolic BP ≥ 140/90 mmHg at screening and not able to be controlled prior to Cycle 1 Day 1 and any change in antihypertensive medications within 1 week prior to Cycle 1 Day 1.
- Thromboembolic (arterial or venous) events within previous 6 months
- Any concurrent therapy for cancer
- Receipt of live attenuated vaccine within 30 days prior to the first dose of investigational product
- Known allergy or hypersensitivity to investigational product(s) or any of the excipients of the investigational product(s)
- Untreated or progressive CNS metastatic disease, any leptomeningeal disease, or cord compression
- History of another primary malignancy
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MedImmune LLClead
Study Sites (20)
Research Site
Washington D.C., District of Columbia, 20007, United States
Research Site
Fort Myers, Florida, 33908, United States
Research Site
St Louis, Missouri, 63156, United States
Research Site
New York, New York, 10065, United States
Research Site
Cleveland, Ohio, 44195, United States
Research Site
Hershey, Pennsylvania, 17033, United States
Research Site
Nashville, Tennessee, 37232, United States
Research Site
Frankston, 3199, Australia
Research Site
Waratah, 2298, Australia
Research Site
Villejuif, 94805, France
Research Site
Barcelona, 08003, Spain
Research Site
Barcelona, 08025, Spain
Research Site
Barcelona, 08035, Spain
Research Site
Barcelona, 08908, Spain
Research Site
Córdoba, 14004, Spain
Research Site
Madrid, 28040, Spain
Research Site
Madrid, 28041, Spain
Research Site
Sabadell, 08208, Spain
Research Site
Seville, 41013, Spain
Research Site
Valencia, 46009, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca Early Oncology
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2020
First Posted
August 21, 2020
Study Start
August 5, 2020
Primary Completion
September 26, 2025
Study Completion
September 26, 2025
Last Updated
July 25, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- 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 deidentified 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
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. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.