Phase I Trial Testing the Safety and Tolerability of Chemoradiation Followed by Chemotherapy + Dostarlimab for Stage IIIC, Node Positive, Endometrial Cancer

M.D. Anderson Cancer Center1 site in 1 country21 target enrollmentJuly 17, 2023

ConditionsEndometrial Cancer

InterventionsDostarlimab Paclitaxel Carboplatin Cisplatin

Overview

Phase: Phase 1
Intervention: Dostarlimab
Conditions: Endometrial Cancer
Sponsor: M.D. Anderson Cancer Center
Enrollment: 21
Locations: 1
Primary Endpoint: Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Status: Recruiting
Last Updated: last month

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

To learn if chemotherapy given in combination with radiation therapy, followed by maintenance therapy, can help to control endometrial cancer. The safety and effects of this study treatment will also be studied

Detailed Description

Primary Objectives: The primary objective of this study is to describe the safety and toxicity of chemoradiation with concurrent immunotherapy, followed by chemotherapy plus concurrent immunotherapy, followed by immunotherapy maintenence in patients with stage IIIC endometrial cancer. Secondary Objectives: The secondary objectives are listed below. * To estimate progression free survival * To describe the time to recurence and the recurrence patterns including extent and location (i.e. isolated versus multi-focal, pelvic versus distant) * To estimate disease specific survival and overall survival Exploratory: * To determine if the presence of deficient mismatch repair (dMMR) or microsatellite instability correlates with progression free survival, disease free survival and 5-year overall survival * To assess patient reported outcomes (PROs) during the course of treatment and follow up

Registry

clinicaltrials.gov

Start Date

July 17, 2023

End Date

March 1, 2028

Last Updated

last month

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

M.D. Anderson Cancer Center

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients are eligible to participate on this study only if they meet all of the following inclusion criteria.
•Has read and understands the informed consent form (ICF) and has given written informed consent prior to any study procedures
•Have surgically staged IIIC, pathologically confirmed endometrial cancer of any histologic subtype and be eligible for adjuvant chemoradiation followed by chemotherapy (Note: Surgical staging is defined as total hysterectomy and lymph node assessment.)
•Enrolled within 8 weeks of surgery and started treatment within 10 weeks of surgery
•Age ≥ 18 years
•Performance Status of ECOG 0 or 1 (see Performance Status Criteria)
•Adequate hematologic function within 14 days prior to enrollment defined as follows:
•Hemoglobin ≥ 9 g/dL
•Platelets ≥ 100,000/mcl
•Absolute neutrophil count (ANC) ≥ 1,500/mcl

Exclusion Criteria

•Patients are not eligible to participate on this study if they meet any of the following exclusion criteria.
•Has not recovered (i.e., to Grade ≤ 1 or to baseline) from prior radiation, major surgery and chemotherapy-induced AEs.
•Surgery ≤ 3 weeks prior to initiating protocol therapy Investigational therapy ≤ 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, prior to initiating protocol therapy.
•Has received prior treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapeutic antibody or other similar agents.
•Has a history of a severe hypersensitivity reaction to monoclonal antibody or dostarlimab and/or its excipients.
•Have active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids. This includes, but is not limited to: a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, GuillainBarre syndrome, myasthenia gravis, systemic autoimmune disease such as SLE, connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome because of the risk of recurrence or exacerbation of disease.
•History of interstitial lung disease or non-infectious pneumonitis except for those induced by radiation therapies.
•Have a diagnosis of immunodeficiency or are receiving daily systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to enrollment:
•Steroids received as CT scan contrast premedication may be enrolled.
•The use of inhaled or topical corticosteroids is allowed.

Arms & Interventions

Adjuvant Therapy During Radiation

Participants will receive an active treatment for 6 cycles. Participants will be on maintenance for 14 cycles, as long as the disease does not get worse. Follow-up will then occur every 6 months for 5 years (from your enrollment date).

Intervention: Dostarlimab