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Monoclonal Antibodies

Dostarlimab + LB-100 for Ovarian Cancer

Phase 1 & 2

Recruiting

Led By Amir Jazaeri, M D

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Willingness and ability to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up

Histology showing recurrent clear cell ovarian, peritoneal, or fallopian tube cancer (mixed histology with predominant clear cell component is acceptable)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 1 year

Awards & highlights

Study Summary

This trial studies if a combo of two drugs can help treat ovarian clear cell carcinoma.

Who is the study for?

This trial is for adults aged 18-75 with recurrent clear cell ovarian, peritoneal, or fallopian tube cancer who've had prior treatment or are platinum-resistant. They must have measurable disease and good organ/bone marrow function. Women of childbearing potential must use contraception due to unknown effects on fetuses.Check my eligibility

What is being tested?

The trial tests the combination of dostarlimab and LB-100 in controlling ovarian clear cell carcinoma. Participants will receive both drugs to see if this duo is more effective than current treatments.See study design

What are the potential side effects?

Potential side effects may include immune-related reactions, fatigue, digestive issues like diarrhea, liver enzyme changes, skin conditions such as rash or itching, hormonal imbalances (like thyroid dysfunction), and possibly an increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am willing and able to follow the study's treatment and visit schedule.

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My cancer is a type of clear cell ovarian, peritoneal, or fallopian tube cancer that has come back.

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My cancer returned or worsened after platinum-based treatment.

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I have a tumor that can be measured and is accessible for biopsy.

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My kidney function, measured by creatinine clearance, is at least 50 mL/min.

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My test results show no PPP2R1A mutations.

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I am between 18 and 75 years old.

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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion; an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dostarlimab + LB-100Experimental Treatment2 Interventions

Dostarlimab will be given by vein over about 30 minutes on Day 1 of each cycle. LB-100 will be given by vein on Days 1-3 of each cycle. The first doses will be given over about 2 hours. After that, doses may be given over as little as 30 minutes.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dostarlimab

2020

Completed Phase 2

~1000

LB-100

2019

Completed Phase 2

~10

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,974 Previous Clinical Trials

1,789,453 Total Patients Enrolled

9 Trials studying Ovarian Carcinoma

3,083 Patients Enrolled for Ovarian Carcinoma

GSK PharmaUNKNOWN

LixteUNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still spaces available to participate in this investigation?

"Clinicaltrials.gov reveals this study is not currently seeking enrolment, despite having been initially advertised on March 31st 2024 and updated most recently on September 26th 2023. Nonetheless, over two-and-a-half thousand other trials are still actively recruiting participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Efficacy of Targeting PP2A in Ovarian Clear Cell Carcinoma Using Dostarlimab and LB-100

2023. "Safety and Efficacy of Targeting PP2A in Ovarian Clear Cell Carcinoma Using Dostarlimab and LB-100". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06065462.