Dostarlimab in Chemoresistant Gestational Trophoblastic Neoplasia

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Brief Title

Dostarlimab in Chemoresistant Gestational Trophoblastic Neoplasia

Official Title

Phase 2 Single Agent Dostarlimab in Chemoresistant Gestational Trophoblastic Neoplasia (GTN)

Brief Summary

      The purpose of this study is to see if Dostarlimab is an effective treatment for Gestational
      Trophoblastic Neoplasia (GTN).
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Proportion of patients with successful normalization of beta hCG

Secondary Outcome

 Proportion of patients with objective response rate (ORR)

Condition

Gestational Trophoblastic Neoplasia

Intervention

Dostarlimab

Study Arms / Comparison Groups

 Dostarlimab Group
Description:  Participants will receive a total of up to 20 cycles of Dostarlimab: 4 cycles of Dostarlimab at a dose of 500 mg on day 1 of each of the 21-day cycle and 16 cycles of Dostarlimab at a dose of 1000 mg on day 1 of each of the 42-day cycle.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

24

Start Date

December 1, 2022

Completion Date

December 1, 2028

Primary Completion Date

December 1, 2026

Eligibility Criteria

        Inclusion Criteria:

          1. Patients with persistent unresectable Gestational Trophoblastic Neoplasia (GTN)
             disease following 2 lines of single agent chemotherapy or persistent or recurrent
             disease following 1 line of multi-agent chemotherapy.

          2. Female patients >18 years old.

          3. Pretreatment archival tissue (if available) must be submitted for correlative studies.
             If pre-treatment tissue is not available, this does not exclude the patient.

          4. Patients must have recovered from the effects of recent surgery or radiotherapy
             (persistent toxicity, CTCAE grade ≤1 except for alopecia, sensory neuropathy, or
             fatigue).

          5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

          6. Patients must have elevated hCG or measurable disease by Response Evaluation Criteria
             in Solid Tumors (RECIST) 1.1

          7. Patients must have adequate organ function.

               1. Absolute neutrophil count ≥ 1,500/ microliter (µL)

               2. Platelets ≥ 100,000/µL

               3. Hemoglobin ≥ 9 g/ deciliter (dL)

               4. Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine
                  clearance ≥ 60 milliliters (mL)/min using the Cockcroft-Gault equation

               5. Total bilirubin ≤ 1.5 x ULN (≤2.0 in patients with known Gilberts syndrome) OR
                  direct bilirubin ≤ 1 x ULN

               6. Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN unless liver
                  metastases are present, in which case they must be ≤ 5 x ULN

               7. International normalized ratio (INR) or prothrombin time (PT) ≤1.5× ULN unless
                  patient is receiving anticoagulant therapy as long as PT or partial
                  thromboplastin (PTT) is within therapeutic range of intended use of
                  anticoagulants.

               8. Activated partial thromboplastin time (aPTT) ≤1.5× ULN unless patient is
                  receiving anticoagulant therapy as long as PT or PTT is within therapeutic range
                  of intended use of anticoagulants

          8. If of childbearing potential, must agree to use a highly effective contraceptive
             method or abstain from activities that could result in pregnancy from enrollment
             through 150 days after the last dose of study treatment or be of non-child bearing
             potential. Contraceptive use should be consistent with local regulations regarding the
             methods of contraception for those participating in clinical studies. Non-child
             bearing potential is defined as follows (by other than medical reasons):

               -  ≥45 years of age and has not had menses for >1 year

               -  Patients who have been amenorrhoeic for <2 years without history of a
                  hysterectomy and oophorectomy must have a follicle stimulating hormone value in
                  the postmenopausal range upon screening evaluation

               -  Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation.
                  Documented hysterectomy or oophorectomy must be confirmed with medical records of
                  the actual procedure or confirmed by an ultrasound. Tubal ligation must be
                  confirmed with medical records of the actual procedure, otherwise the patient
                  must be willing to use a highly effective contraception method throughout the
                  study, starting with signing the Informed Consent Form (ICF) through 150 days
                  after the last dose of study treatment. See Section 4.11 for a list of highly
                  effective birth control methods. Information must be captured appropriately
                  within the site's source documents. Note: Abstinence is acceptable if this is the
                  established and preferred contraception for the patient.

          9. Participant of childbearing potential must have the treating physician document that
             positive pregnancy test does not represent a clinically viable pregnancy.

         10. Participant must agree to not breastfeed during the study or for 150 days after the
             last dose of study treatment.

         11. Participant must be able to understand the study procedures and agree to participate
             in the study by providing written informed consent.

         12. Life expectancy of at least 16 weeks.

        Exclusion Criteria:

          1. Prior therapy with anti-Programed Death (PD)1/Programed Death Ligand-1 (PD-L1) or
             anti-CTLA4 antibody

          2. Participant must not be simultaneously enrolled in any interventional clinical trial.

          3. Participant must not have had major surgery ≤3 weeks prior to initiating protocol
             therapy and participant must have recovered from any surgical effects.

          4. Participant must not have received investigational therapy ≤ 4 weeks, or within a time
             interval less than at least 5 half-lives of the investigational agent, whichever is
             shorter, prior initiating protocol therapy.

          5. Participant must not have a known hypersensitivity to dostarlimab components or
             excipients.

          6. Participant must not have a serious, uncontrolled medical disorder, non-malignant
             systemic disease, or active, uncontrolled infection. Examples include, but are not
             limited to, uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial
             infarction, uncontrolled major seizure disorder, unstable spinal cord compression,
             superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining
             informed consent.

          7. Patient has a known additional malignancy that progressed or required active treatment
             within the last 2 years. Exceptions include basal cell carcinoma of the skin, squamous
             cell carcinoma of the skin that has undergone potentially curative therapy, or in situ
             cancer that is considered to be low risk for progression by the Investigator.

          8. Participant has a diagnosis of immunodeficiency or has received systemic steroid
             therapy or any other form of immunosuppressive therapy within 7 days prior to
             initiating protocol therapy.

          9. Participant has a known history of human immunodeficiency virus (type 1 or 2
             antibodies).

         10. Participant has known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg]
             reactive) or hepatitis C (HCV) (e.g., hepatitis C virus (HCV) ribonucleic acid
             [qualitative] is detected).

         11. Participant has an active autoimmune disease that has required systemic treatment in
             the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or
             immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic
             corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is
             not considered a form of systemic treatment.

         12. Participant must not have a history of interstitial lung disease.

         13. Participant is considered a poor medical risk that would interfere with cooperation
             with the requirements of the study.

         14. Participant has received a live vaccine within 30 days of before first dose of study
             treatment.

         15. Subject is pregnant or breastfeeding or is expecting to conceive children within the
             projected duration of the study, through 150 days after the last dose of study
             treatment.
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Marilyn Huang, MD, 305-243-6160, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT05405192

Organization ID

20210967


Responsible Party

Sponsor

Study Sponsor

University of Miami

Collaborators

 GlaxoSmithKline

Study Sponsor

Marilyn Huang, MD, Principal Investigator, University of Miami


Verification Date

July 2022