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Safety Study of SAR442720 in Combination With Pembrolizumab in Patients With 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04418661
Recruitment Status : Recruiting
First Posted : June 5, 2020
Last Update Posted : March 29, 2021
Sponsor:
Collaborator:
Revolution Medicines, Inc.
Information provided by (Responsible Party):
Sanofi

Brief Summary:

Primary Objective:

  • To characterize the safety and tolerability of SAR442720 in combination with pembrolizumab in patients with advanced solid tumors including NSCLC who progressed on anti-PD-1/PD L1 containing therapy and advanced colorectal cancer (CRC) after progression to all standard of care (SOC) therapy.
  • To define the MTD and RP2D for the combination of SAR442720 and pembrolizumab in patients with solid tumors

Secondary Objective:

  • To document the pharmacokinetic (PK) of SAR442720 in combination with pembrolizumab and to document the PK of pembrolizumab in combination with SAR442720
  • To estimate the anti-tumor effects of SAR442720 in combination with pembrolizumab in all participants

Condition or disease Intervention/treatment Phase
Metastatic Neoplasm Drug: SAR442720 Drug: Pembrolizumab Phase 1

Detailed Description:

This open label Phase 1 multicenter study is designed to evaluate the safety and maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of SAR442720 in combination with pembrolizumab in participants with solid tumors.

The expected duration of study intervention for participants may vary, based on progression date; median expected duration of study per participant is estimated to be about 10 months (up to 1 month for screening, a median of 6 months for treatment, and a median of 3 months for long term follow-up).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-label, Multicenter, Safety Study of SAR442720 in Combination With Pembrolizumab in Patients With Advanced Malignancies
Actual Study Start Date : June 16, 2020
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SAR442720
SAR442720 (also known as RMC-4630) will be administered orally with pembrolizumab which is given by IV once every 3 weeks (Q3W). The dose of SAR442720 will be escalated or de-escalated depending on the emerging safety data of the combination.
Drug: SAR442720
Pharmaceutical form:Capsule Route of administration: Oral

Drug: Pembrolizumab
Pharmaceutical form:Sterile Lyophilized powder for reconstitution Route of administration: Infusion




Primary Outcome Measures :
  1. Incidence of study-drug related Dose Limiting Toxicities (DLTs) [ Time Frame: 21 days ]
    Incidence and nature of DLTs assessed as the occurrence of adverse events (AE) graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.

  2. Incidence of Adverse Events [ Time Frame: up to 2 years ]
    Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) graded according to the NCI CTCAE v5 for the combination of SAR442720 and pembrolizumab.


Secondary Outcome Measures :
  1. PK of SAR442720 [ Time Frame: up to 2 years ]
    Plasma concentrations of SAR442720.

  2. PK of pembrolizumab [ Time Frame: up to 2 years ]
    Serum concentrations of pembrolizumab.

  3. Objective response rate (ORR) [ Time Frame: up to 2 years ]
    Percentage of participants with a best response of complete response (CR) or partial response (PR) of SAR442720 and pembrolizumab based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

  4. Duration of response (DoR) [ Time Frame: up to 2 years ]
    Duration of response per RECIST v1.1 is defined as the interval from the first documentation of CR or PR to the earlier of the first documentation of definitive disease progression or death due to any cause, whichever occurs first.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria :

  • Participants must be ≥ 18 years of age
  • Histologically proven diagnosis of advanced solid tumors
  • Participants must have one or more of the following molecular aberrations: KRAS mutations and amplifications, BRAF Class 3 mutations, or NF1 LOF mutations
  • At least 1 measurable disease per RECIST 1.1 criteria.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Woman of childbearing potential must agree to follow contraceptive guidance
  • Capable of giving signed informed consent

Exclusion criteria:

  • Predicted life expectancy <3 months.
  • Primary central nervous system (CNS) tumors.
  • Symptomatic or impending cord compression.
  • History of cerebrovascular stroke or transient ischemic attack within previous 6 months.
  • Prior solid organ or hematologic transplant.
  • History or current retinal pigment epithelial detachment (RPED), central serous retinopathy, retinal vascular occlusion (RVO), neovascular macular degeneration
  • Any clinically significant cardiac disease
  • Active, known or suspected autoimmune disease
  • History of or current interstitial lung disease or pneumonitis
  • Receipt of a live-virus vaccination within 28 days of planned treatment start
  • Known infection with human immunodeficiency virus (HIV), known uncontrolled hepatitis B infection, active tuberculosis, or severe infection requiring parenteral antibiotic treatment.
  • Inadequate hematologic, hepatic and renal function
  • Known second malignancy
  • Impairment of gastrointestinal function
  • Any unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a participant, impact their expected survival through the end of the study participation, and/or impact their ability to comply with the protocol.
  • History of severe allergic reaction to any of the study intervention components

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.


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): NCT04418661


Contacts
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Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext option 6 Contact-US@sanofi.com

Locations
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United States, California
Investigational Site Number 8400002 Recruiting
Orange, California, United States, 92868
United States, Texas
Investigational Site Number 8400001 Recruiting
Houston, Texas, United States, 77030
Australia
Investigational Site Number 0360003 Recruiting
Heidelberg West, Australia, 3081
Investigational Site Number 0360002 Recruiting
Randwick, Australia, 2031
Investigational Site Number 0360001 Recruiting
Woolloongabba, Australia, 4102
Korea, Republic of
Investigational Site Number 4100001 Recruiting
Seoul, Korea, Republic of, 03722
Spain
Investigational Site Number 7240001 Recruiting
Madrid / Madrid, Spain, 28040
Investigational Site Number 7240002 Recruiting
Madrid / Madrid, Spain, 28050
Taiwan
Investigational Site Number 1580002 Recruiting
Tainan, Taiwan, 704
Investigational Site Number 1580001 Recruiting
Taipei, Taiwan, 100
Sponsors and Collaborators
Sanofi
Revolution Medicines, Inc.
Investigators
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Study Director: Clinical Sciences & Operations Sanofi
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT04418661    
Other Study ID Numbers: TCD16210
U1111-1244-2555 ( Other Identifier: UTN )
First Posted: June 5, 2020    Key Record Dates
Last Update Posted: March 29, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms
Neoplastic Processes
Pathologic Processes
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents