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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT05819892
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Paclitaxel — DRUG
    Given by IV (vein)
  • Carboplatin — DRUG
    Given by IV (vein)
  • Dostarlimab — DRUG
    Given by IV (vein)
  • Cisplatin — DRUG
    Given by IV (vein)

Study Details

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

Key Dates

Start date
Jul 17, 2023
Status verified
Jun 2026
Primary completion
Mar 1, 2027
Completion
Mar 1, 2028

Study Design

Enrollment
21 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Adjuvant Therapy During Radiation
    Participants will receive an active treatment for 6 cycles. Participants will be on Immunotherapy (Dostarlimab) up to 2 years (starting with Dostarlimab treatment at cycle 3), as long as the disease does not get worse or have unacceptable toxicity. Follow- up will then occur every 6 months for 5 years from active treatment.
  • Experimental: Adjuvant Therapy After Radiation
    Participants will receive an active treatment for 6 cycles. Participants will be on Immunotherapy (Dostarlimab) up to 2 years (starting with Dostarlimab treatment at cycle 3), as long as the disease does not get worse or have unacceptable toxicity. Follow- up will then occur every 6 months for 5 years from active treatment.
  • Experimental: Immunotherapy after Radiation and Chemo
    Participants will receive an active treatment for 6 cycles. Participants will be on Immunotherapy (Dostarlimab) up to 2 years (starting with Dostarlimab treatment at cycle 3), as long as the disease does not get worse or have unacceptable toxicity. Follow- up will then occur every 6 months for 5 years from active treatment.

Primary Outcome Measure

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 [ Time Frame: through study completion; an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Pamela Soliman, MD
[email protected]
713-745-2352
Pamela Soliman, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Houston, TX

By condition
Endometrial cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
M D Anderson Cancer Center· Houston, TX

Related Studies