What side effects are associated with this type of intervention?

PD-1 inhibitors like Dostarlimab are known to cause side effects such as fatigue, rash, diarrhea, and pneumonitis. Severe immune-related adverse events can also occur, including colitis, hepatitis, endocrinopathies, and nephritis. For PP2A inhibitors like LB-100, specific side effect data is limited, but potential side effects may include gastrointestinal disturbances, hematologic toxicity, and fatigue. Other common treatments for ovarian carcinoma, such as chemotherapy with agents like carboplatin and paclitaxel, can cause nausea, vomiting, hair loss, neuropathy, and myelosuppression.

What prior FDA approvals exist?

The FDA has approved several treatments for ovarian carcinoma, particularly focusing on immunotherapies and targeted therapies. Pembrolizumab, a PD-1 inhibitor, has been approved for use in patients with advanced ovarian cancer exhibiting microsatellite instability-high (MSI-H) or mismatch repair deficiency (dMMR). Additionally, PARP inhibitors like olaparib, niraparib, and rucaparib have been approved for maintenance therapy in patients with recurrent ovarian cancer who have responded to platinum-based chemotherapy. While specific information on PP2A inhibitors like LB-100 is limited, the combination of immunotherapy and targeted agents represents a promising area of ongoing research.

What other types of research exist?

Promising alternatives for ovarian carcinoma treatment in 2024 include: 1) Pembrolizumab (another PD-1 inhibitor) which has shown efficacy in various cancers including ovarian carcinoma. 2) PARP inhibitors like Olaparib, which are effective in patients with BRCA mutations. 3) Bevacizumab, an anti-angiogenic agent, often used in combination with chemotherapy. 4) Combination therapies such as Pembrolizumab with chemotherapy or other targeted agents, which are being actively studied in clinical trials.

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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)

Must not have

Prior treatment with anti-CTLA-4 or anti-PDL-1/PD-1 antibodies

Any concurrent chemotherapy, immunotherapy, or hormonal therapy for cancer treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of two drugs, dostarlimab and LB-100, in patients with recurrent ovarian clear cell carcinoma. Dostarlimab boosts the immune system to fight cancer, and LB-100 makes cancer cells easier to kill. The goal is to see if this combination can control the cancer better than existing treatments.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with anti-CTLA-4 or anti-PD-1/PD-L1 antibodies.

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I am not currently on chemotherapy, immunotherapy, or hormonal therapy for cancer.

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I do not have active infections like TB, hepatitis B or C, or HIV.

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I have hepatitis C antibodies but no active virus according to PCR tests.

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My cancer is identified as mismatch repair deficient or has high microsatellite instability.

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I have a skin condition that doesn't need treatment with pills or injections.

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My hypothyroidism is under control with medication.

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I have had a transplant of bone marrow or another organ.

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I do not have any serious ongoing illnesses that would affect my participation in the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 3

~1760

LB-100

2019

Completed Phase 2

~10

0 / 17Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for ovarian carcinoma include platinum-based chemotherapy, bevacizumab, PD-1 inhibitors like dostarlimab, and PP2A inhibitors like LB-100. Platinum-based chemotherapy (e.g., carboplatin) works by causing DNA damage that leads to cancer cell death. Bevacizumab is an anti-angiogenic agent that inhibits the formation of new blood vessels, starving the tumor of nutrients. PD-1 inhibitors, such as dostarlimab, enhance the immune system's ability to recognize and attack cancer cells by blocking the PD-1 pathway, which tumors use to evade immune detection. PP2A inhibitors like LB-100 target a protein phosphatase involved in cell growth and survival, potentially making cancer cells more susceptible to other treatments. These mechanisms are crucial for ovarian carcinoma patients as they offer multiple avenues to target and kill cancer cells, improving treatment efficacy and patient outcomes.