RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2023-07-17

Study Completion:2028-03-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05819892

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Has read and understands the informed consent form (ICF) and has given written informed consent prior to any study procedures 2. 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.) 3. Enrolled within 8 weeks of surgery and started treatment within 10 weeks of surgery 4. Age ≥ 18 years 5. Performance Status of ECOG 0 or 1 (see Performance Status Criteria) 6. 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 7. Adequate renal function within 14 days prior to enrollment defined as follows: Creatinine 8. 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 9. 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. 10. Prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial (i.e. non-melanomatous skin cancer).	1. Has not recovered (i.e., to Grade ≤ 1 or to baseline) from prior radiation, major surgery and chemotherapy-induced AEs. 2. 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. 3. Has received prior treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapeutic antibody or other similar agents. 4. Has a history of a severe hypersensitivity reaction to monoclonal antibody or dostarlimab and/or its excipients. 5. 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. 6. History of interstitial lung disease or non-infectious pneumonitis except for those induced by radiation therapies. 7. 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). 8. Have received a live vaccine within 30 days of starting trial therapy. 9. Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; and cirrhosis. 10. 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. 11. Have received any of the prohibited medications listed in Section 7.2. 12. Has leptomeningeal disease, carcinomatous meningitis, symptomatic brain metastases, or radiologic signs of CNS hemorrhage. Note: Asymptomatic brain metastases (i.e, off corticosteroids and anticonvulsants for at least 7 days) are permitted. 13. Known human immunodeficiency virus (HIV)-infected patients. 14. Women of childbearing potential (WoCBP) who have been not been permanently or surgically sterilized and are capable of procreation

Inclusion Criteria

Exclusion Criteria

1. Has read and understands the informed consent form (ICF) and has given written informed consent prior to any study procedures
2. 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.)
3. Enrolled within 8 weeks of surgery and started treatment within 10 weeks of surgery
4. Age ≥ 18 years
5. Performance Status of ECOG 0 or 1 (see Performance Status Criteria)
6. 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
7. Adequate renal function within 14 days prior to enrollment defined as follows: Creatinine
8. 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
9. 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.
10. Prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial (i.e. non-melanomatous skin cancer).

1. Has not recovered (i.e., to Grade ≤ 1 or to baseline) from prior radiation, major surgery and chemotherapy-induced AEs.
2. 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.
3. Has received prior treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapeutic antibody or other similar agents.
4. Has a history of a severe hypersensitivity reaction to monoclonal antibody or dostarlimab and/or its excipients.
5. 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.
6. History of interstitial lung disease or non-infectious pneumonitis except for those induced by radiation therapies.
7. 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).
8. Have received a live vaccine within 30 days of starting trial therapy.
9. Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; and cirrhosis.
10. 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.
11. Have received any of the prohibited medications listed in Section 7.2.
12. Has leptomeningeal disease, carcinomatous meningitis, symptomatic brain metastases, or radiologic signs of CNS hemorrhage. Note: Asymptomatic brain metastases (i.e, off corticosteroids and anticonvulsants for at least 7 days) are permitted.
13. Known human immunodeficiency virus (HIV)-infected patients.
14. Women of childbearing potential (WoCBP) who have been not been permanently or surgically sterilized and are capable of procreation

Contacts and Locations

Study Contact

Pamela Soliman, MD

CONTACT

713-745-2352

psoliman@mdanderson.org

Principal Investigator

Pamela Soliman, MD

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Pamela Soliman, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-17

Study Completion Date2028-03-01

Study Record Updates

Study Start Date2023-07-17

Study Completion Date2028-03-01

Terms related to this study

Additional Relevant MeSH Terms

Endometrial Cancer