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

NCT05819892 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 2021-0618NCI-2023-03071
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

Conditions

Endometrial Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  through study completion; an average of 1 year

Study Arms (3)

Adjuvant Therapy During Radiation

EXPERIMENTAL

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).

Drug: Paclitaxel; Drug: Carboplatin; Drug: Dostarlimab; Drug: Cisplatin

Adjuvant Therapy After Radiation

EXPERIMENTAL

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).

Drug: Paclitaxel; Drug: Carboplatin; Drug: Dostarlimab; Drug: Cisplatin

Immunotherapy after Radiation and Chemo

EXPERIMENTAL

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).

Drug: Paclitaxel; Drug: Carboplatin; Drug: Dostarlimab; Drug: Cisplatin

Interventions

Paclitaxel DRUG

Given by IV (vein)

Also known as: Taxol

Adjuvant Therapy After Radiation; Adjuvant Therapy During Radiation; Immunotherapy after Radiation and Chemo

Cisplatin DRUG

Given by IV (vein)

Also known as: Platinol®-AQ, Platinol®, CDDP

Adjuvant Therapy After Radiation; Adjuvant Therapy During Radiation; Immunotherapy after Radiation and Chemo

Carboplatin DRUG

Given by IV (vein)

Also known as: Paraplatin®

Adjuvant Therapy After Radiation; Adjuvant Therapy During Radiation; Immunotherapy after Radiation and Chemo

Dostarlimab DRUG

Given by IV (vein)

Adjuvant Therapy After Radiation; Adjuvant Therapy During Radiation; Immunotherapy after Radiation and Chemo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Adequate renal function within 14 days prior to enrollment defined as follows: Creatinine
• ≤ 2 x laboratory upper limit of normal (ULN) or CrCl ≥60ml/min
• Adequate hepatic function within 14 days prior to enrollment defined as follows:
• Bilirubin ≤ 1.5 x ULN (patients with known Gilbert's disease who have bilirubin level ≤ 2 x ULN may be enrolled)
• ALT and AST ≤ 2.5 x ULN
• Adequate coagulation within 14 days prior to enrollment defined as INR or PT/aPTT ≤ 1.5 x ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants.

You may not qualify if:

• 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.
• The use of mineralocorticoids (e.g., fludrocortisone) for orthostatic hypotension or adrenocortical insufficiency is allowed.
• The use of physiologic doses of corticosteroids may be allowed and in consultation with the study chair (e.g. 10 mg of prednisone used for replacement therapy for adrenal insufficiency).
• Have received a live vaccine within 30 days of starting trial therapy.
• Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; and cirrhosis.
• Evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load, tested positive for the presence of hepatitis B surface antigen, or have a positive hepatitis C antibody test result at screening or within 3 months prior to the first dose of study treatment.
• Uncontrolled intercurrent illness including (but not limited to): ongoing or active infection (except for uncomplicated urinary tract infection), interstitial lung disease or active, non-infectious pneumonitis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Paclitaxel; Carboplatin; dostarlimab; Cisplatin

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Pamela Soliman, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pamela Soliman, MD

CONTACT

713-745-2352; psoliman@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: April 19, 2023
• Study Start: July 17, 2023
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: March 11, 2026

Record last verified: 2026-03

Locations

US (1)