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Two Part (Phase1b/ Phase3) Trial of Subcutaneous Dostarlimab Plus Carboplatin-Paclitaxel in Participants With Primary Advanced or Recurrent Endometrial Cancer

ConditionEndometrial Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorGlaxoSmithKline

About this trial

This is an open-label study, meaning both the researchers and participants will know which treatment is being given.

The study has two parts. In Part 1, researchers will identify the most suitable SC dose. In Part 2, participants will be randomly assigned by chance to receive dostarlimab as either an SC injection or an IV infusion. All participants will also receive carboplatin and paclitaxel. Treatment may continue for up to 3 years, with participants closely monitored throughout the study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participant is at least 18 years of age (or the legal age of consent in the jurisdiction in which the trial is taking place) at the time of signing the Informed Consent Form (ICF).

Participant has primary Stage III or Stage IV disease or first recurrent EC.

Participant must have a documented Mismatch repair (MMR)/Microsatellite Instability (MSI) status.

Participant is capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the ICF and in the protocol.

Disqualifiers

Participant has history of or active autoimmune disease that has required systemic treatments within the 2 years prior to screening.

Participant has a history of severe allergic and/or anaphylactic reactions to chimeric, human or humanized antibodies, fusion proteins, or known hypersensitivity to carboplatin, paclitaxel or dostarlimab components or excipients.

Participant has received prior therapy with anti-programmed death protein 1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti-PD-L2 agent.

Participant has known uncontrolled brain or central nervous system (CNS) metastases.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Dostarlimab

    Biological/Vaccine

    Dostarlimab will be administered as SC injection and IV infusion

  • Carboplatin and paclitaxel

    Drug

    Carboplatin and paclitaxel will be administered as an IV infusion

Treatment groups

380 Participants
are divided into 2 treatment groups
Group A: Part 1 (Phase 1b) SC dostarlimab and IV dostarlimabExperimental treatment 2 interventions
Group B: Part 2 (Phase 3): SC dostarlimab (experimental) or IV dostarlimab (standard of care)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Part 1: Serum Trough Concentration (Ctrough) After First Dose of Dostarlimab

Time frame
Up to 42 days
2

Part 1: Area Under the Concentration-time Curve (AUC) of Dostarlimab

Time frame
Up to 42 days
3

Part 2: Observed Ctrough of Dostarlimab

Time frame
Up to 168 days
4

Part 2: Model-predicted (MP) AUC of Dostarlimab

Time frame
Up to 21 days

Secondary outcomes

1

Part 1: Ctrough of Dostarlimab

Time frame
Up to 42 days
2

Part 1: AUC of Dostarlimab

Time frame
Up to 42 days
3

Part 1: Maximum Observed Concentration (Cmax) of Dostarlimab

Time frame
Up to 42 days
4

Part 1: Time to Peak Drug Concentration (Tmax) of Dostarlimab

Time frame
Up to 42 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

GlaxoSmithKline

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: