A Study to Evaluate the Safety of Dostarlimab in Adult Participants in India With Primary Advanced or Recurrent Endometrial Cancer

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorGlaxoSmithKline

About this trial

This study will evaluate the safety of dostarlimab in combination with carboplatin and paclitaxel followed by monotherapy when administered as a first-line treatment in advanced or recurrent endometrial cancer (EC).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participant with greater than or equals to (>=) 18 years of age, at the time of signing the informed consent.

Participant has histologically or cytologically proven EC with recurrent or advanced disease.

Participant must have primary Stage III or Stage IV disease or first recurrent EC with a low potential for cure by radiation therapy or surgery alone or in combination based on investigator's assessment.

Eligible for dostarlimab treatment according to the approved prescribing information and the investigator's clinical judgement.

Disqualifiers

Participant has had greater than (>) 1 recurrence of endometrial cancer.

Participant has a concomitant malignancy, or participant has a prior non endometrial invasive malignancy who has been disease-free for less than (<) 3 years or who received any active treatment in the last 3 years for that malignancy.

Participant has known uncontrolled central nervous system metastases, carcinomatosis meningitis, or both.

Participant is considered a poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease, or active infection requiring systemic therapy.

Trial design

Design model

Single group

Treatments tested in this trial

  • Dostarlimab

    Drug

    Dostarlimab will be administered.

  • Carboplatin

    Drug

    Carboplatin will be administered.

  • Paclitaxel

    Drug

    Paclitaxel will be administered.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Participants receiving Dostarlimab with Carboplatin + Paclitaxel followed by Dostarlimab MonotherapyExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Number of participants with Grade 3 or greater treatment-emergent adverse events (TEAEs) up to Week 49

Time frame
Up to Week 49

Secondary outcomes

1

Number of participants with Grade 3 or greater TEAEs up to Week 170

Time frame
Up to Week 170
2

Number of participants with TEAEs up to Week 49

Time frame
Up to Week 49
3

Number of participants with TEAEs up to Week 170

Time frame
Up to Week 170
4

Number of participants with Immune-related adverse events (irAEs) up to Week 49

Time frame
Up to Week 49

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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