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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04197219
Other study ID # CASE4819
Secondary ID
Status Withdrawn
Phase Phase 2
First received
Last updated
Start date February 1, 2021
Est. completion date December 1, 2026

Study information

Verified date November 2020
Source Case Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main purpose of this study is to see if adding the experimental medication, axitinib, to usual treatment with pembrolizumab will work better than pembrolizumab alone. The study team will look at overall safety and side effects of the combination of axitinib and pembrolizumab to see how well it is tolerated. Researchers will also want to take some research blood samples to explore what effects the combination of treatment has on participants' cells and immune system and to see if there are things in participants' blood that can predict a response or resistance to the combined treatment.


Description:

This is a Phase 2, open label study of pembrolizumab in combination with axitinib in adult women with recurrent endometrial cancer with deficient mismatch repair system. Twenty-six participants in total will be enrolled into the study. All participants enrolled will receive pembrolizumab as standard of care combined with axitinib. Axitinib is approved by the Food and Drug Administration (FDA) for treatment in certain participants with advanced renal cell cancer but is considered investigational (experimental) in this study. However, it is not FDA approved for recurrent endometrial cancer. Axitinib is a type of drug called a tyrosine kinase inhibitor. It is thought to work by blocking tumor vasculature and decreasing the blood supply to the tumor. Also it has been shown to improve the function of immune cells within the tumor which may enable them to kill the tumor. Pembrolizumab is an immunotherapy that is FDA approved to treat participants with recurrent endometrial cancer with deficient mismatch repair system (dMMR). dMMR means having genetic changes within the tumor that make it unstable and potentially able to benefit from immunotherapy. Pembrolizumab works by improving the function of the immune cells enabling them to kill cancer cells. Axitinib given in combination with pembrolizumab has not been tested for endometrial cancer. In this study the combination of axitinib and pembrolizumab is experimental because it is not approved by the Food and Drug Administration (FDA).


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Pembrolizumab
200 mg IV day 1 of each cycle every 21 days
Axitinib
5 mg PO BID continuously

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Case Comprehensive Cancer Center

References & Publications (33)

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Outcome

Type Measure Description Time frame Safety issue
Other Translational endpoints Translational markers to predict resistance and response to therapy. Identify genomic, immune related markers that can predict response and/or resistance to the combined therapy. 12 months from end of treatment
Primary Objective response rate (ORR) at 12 weeks by RECIST 1.1 Percent of participants with ORR, defined as those having either a partial or complete response (according to RECIST 1.1) per investigator determination at 12 weeks from the date of study enrollment.
Complete response (CR): Disappearance of all target lesions
Partial response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD
Up to 12 weeks from start of treatment
Secondary Average overall Survival (OS) Average number in months from the date of study enrollment to the date of death (any cause) or last known date of follow up if otherwise lost to follow up. Assessed up to 60 months
Secondary Clinical benefit rate Clinical benefit, defined by percent of participants with ORR and stable disease at 12 weeks Up to 12 weeks from start of treatment
Secondary Number of participants with grade 3 and 4 immune and non-immune related toxicities assessed via NCI CTCAE v.5.03 Number of participants with grade 3 and 4 immune and non-immune related toxicities assessed via National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v.5.03 90 days from end of treatment
Secondary Average progression-free survival (PFS) Average number of months from the date of study enrollment to the date of an event of disease progression (according to RECIST 1.1) per investigator determination or to the date of death (any cause). 12 months from end of treatment
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