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OT-101 with Pembrolizumab for Mesothelioma

This study is testing a combination of two drugs, OT-101 and pembrolizumab, for people with malignant pleural mesothelioma. This is a type of cancer that affects the lining of the lungs. You might be able to join if your cancer has not responded to previous treatments like anti-PD-1, anti-PD-L1, or anti-CTLA-4 medications. Researchers want to see how well this drug combination works and how safe it is at different doses. The main goal is to find out the overall response rate (ORR), meaning how many people's tumors shrink or disappear, which will be measured after about 24 months. The study plans to enroll 63 participants, but its current status is unclear.

Study design
This is a Phase 2, open-label study, meaning you and your doctors will know which treatment you are receiving. It is a single-arm study, so everyone receives the same treatment combination. The study will first determine the safest dose of OT-101 in combination with pembrolizumab.
What's involved
Participants will receive OT-101 as a continuous intravenous (IV) infusion for four days every two weeks, in combination with pembrolizumab. The study will involve an initial dose-escalation phase to find the recommended dose.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, overall response rate, will be measured at approximately 24 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05425576

OT-101 in Combination With Pembrolizumab in Subjects With Malignant Pleural Mesothelioma Failing to Respond to Checkpoint Inhibition

Not Yet Recruiting
PHASE2Ages 18+InterventionalTreatment
Oncotelic Inc.
~63 participants
Updated 2024-03-15 on ClinicalTrials.gov
What's tested:OT-101

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Determination of ORR for the combination of OT-101 and pembrolizumab in subjects
Measured over approximately 24 months

Conditions

Malignant Pleural Mesothelioma

Explore related trials

Pleural Malignant Mesothelioma

Where it's being run

1 sites across 1 states
Pennsylvania1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)
Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) 6. Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years. 7. Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 10 days prior to first dose of study intervention. 8. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients. 9. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed. 10. Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. 11. Has an active infection requiring systemic therapy. 12. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \[HBsAg\] reactive) or known active Hepatitis C virus (defined as HCV RNA \[qualitative\] is detected) infection. 13. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator. 14. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 15. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment. 16. Has had an allogenic tissue/solid organ transplant.

What this trial measures

  • Determination of ORR for the combination of OT-101 and pembrolizumab in subjectsapproximately 24 months

    modified RECIST (mRECIST; v1.1)