Dostarlimab + LB-100 for Ovarian Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Amir A. Jazaeri

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Immunosuppressants, Live vaccines

Disqualifiers: Autoimmune disorders, Active infection, Uncontrolled illness, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that you cannot have any concurrent chemotherapy, immunotherapy, or hormonal therapy for cancer treatment. It's best to discuss your current medications with the study team to see if they might interfere with the trial.

What safety data exists for Dostarlimab and LB-100 in humans?

Dostarlimab has been approved for use in certain cancers and has shown a low risk of causing significant immune reactions in patients, with only a small percentage developing antibodies against it. There is no specific safety data available for the combination of Dostarlimab and LB-100 in the provided research articles. ^{1 2 3 4 5}

What makes the drug Dostarlimab + LB-100 unique for ovarian cancer?

Dostarlimab is a monoclonal antibody that targets the PD-1 receptor, helping the immune system attack cancer cells, and it has shown promise in treating various cancers, including endometrial cancer. The combination with LB-100, which is not widely used in standard treatments, may offer a novel approach by potentially enhancing the immune response against ovarian cancer. ^{1 2 3 4 6}

Research Team

Amir A. Jazaeri

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

Your platelet count is greater than or equal to 100 x 109/L (more than 100,000/mm3).

I am considered post-menopausal due to not having periods for 12 months without other medical reasons.

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

Exclusion Criteria

Concurrent treatment on another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study

Subjects with irreversible toxicity not reasonably expected to be exacerbated by the treatment with investigational therapy may be included only after consultation with the primary investigator

I haven't had active disease in the last 5 years and have consulted the primary investigator.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dostarlimab and LB-100. Dostarlimab is given by vein on Day 1 of each cycle, and LB-100 is given by vein on Days 1-3 of each cycle.

6-12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including overall survival and progression-free survival.

6-12 months

Treatment Details

Interventions

• Dostarlimab (Monoclonal Antibodies)
• LB-100 (Other)

Trial Overview 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.

Participant Groups

Group I: Dostarlimab + LB-100 Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Dr. Peter WT Pisters

M.D. Anderson Cancer Center

Chief Executive Officer since 2017

MD from University of Western Ontario

Dr. Jeffrey E. Lee

M.D. Anderson Cancer Center

Chief Medical Officer

MD from Stanford University School of Medicine

GSK Pharma

Collaborator

Trials

1

Recruited

20+

Lixte

Collaborator

Trials

1

Recruited

20+

Findings from Research

Dostarlimab is a monoclonal antibody that targets the PD-1 receptor and has been approved for treating adult patients with mismatch repair deficient recurrent or advanced endometrial cancer based on promising results from the GARNET trial.

The approval of dostarlimab in the EU and USA marks a significant milestone in cancer treatment, highlighting its potential efficacy in targeting specific cancer types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dostarlimab: First Approval. Markham, A.[2021]

Dostarlimab-gxly (Jemperli) has received accelerated approval from the FDA for treating adults with mismatch repair deficient recurrent or advanced endometrial cancer and solid tumors, indicating its potential effectiveness in these specific cancer types.

This approval highlights the importance of targeted therapies in oncology, particularly for patients with specific genetic markers that may influence treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Drug for Mismatch Repair Deficient Endometrial Cancer and Solid Tumors. Aschenbrenner, DS.[2023]

Dostarlimab (JEMPERLI) is a PD-1 monoclonal antibody that has received rapid FDA approval for treating adult patients with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer, showing promising tumor response rates.

A clinical trial (NCT04165772) reported a remarkable 100% remission rate for rectal cancer patients treated with Dostarlimab, highlighting the potential of matching tumor genetics with targeted therapies, and the trial is ongoing for other cancer types like gastric, prostate, and pancreatic cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dostarlimab: A Review. Costa, B., Vale, N.[2022]

In a study involving 478 patients, dostarlimab, an anti-PD-1 monoclonal antibody, showed a low incidence of treatment-emergent antidrug antibodies (ADAs) at 2.5%, indicating a favorable safety profile compared to other similar therapies.

Despite the presence of ADAs in a small number of patients, there was no evidence of reduced efficacy or safety for dostarlimab, supporting its use as an effective treatment for various solid tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Integrated Analysis of Dostarlimab Immunogenicity. Lu, S., Bowsher, RR., Clancy, A., et al.[2022]

Dostarlimab showed promising antitumor activity in patients with recurrent/advanced non-small cell lung cancer (NSCLC) who had progressed after platinum-based chemotherapy, achieving an immune-related objective response rate (irORR) of 26.9% across various PD-L1 expression levels.

The treatment was generally well-tolerated, with fatigue being the most common severe adverse event (4.5%), and immune-related treatment-emergent adverse events occurring in 28.4% of patients, indicating an acceptable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Dostarlimab in Patients With Recurrent/Advanced Non-small Cell Lung Cancer: Results from Cohort E of the Phase I GARNET Trial. Moreno, V., Roda, D., Pikiel, J., et al.[2023]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Dostarlimab: First Approval. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

New Drug for Mismatch Repair Deficient Endometrial Cancer and Solid Tumors. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Comparative analysis of PD-1 target engagement of dostarlimab and pembrolizumab in advanced solid tumors using ex vivo IL-2 stimulation data. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Dostarlimab: A Review. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

An Integrated Analysis of Dostarlimab Immunogenicity. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Dostarlimab in Patients With Recurrent/Advanced Non-small Cell Lung Cancer: Results from Cohort E of the Phase I GARNET Trial. [2023]