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TGF-b2 Inhibitor
OT-101 + Pembrolizumab for Mesothelioma
Phase 2
Waitlist Available
Research Sponsored by Oncotelic Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Male/female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of Malignant Pleural Mesothelioma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 24 months
Awards & highlights
Study Summary
This trial is testing a new treatment for mesothelioma that combines two drugs. They will assess how well it works and how safe it is.
Who is the study for?
This trial is for adults with Malignant Pleural Mesothelioma who didn't respond to previous treatments including anti-PD-1/L1 or anti-CTLA-4 antibodies, possibly with chemotherapy. They must have measurable disease, adequate organ function, and agree to contraception. Excluded are those with a recent second cancer, active autoimmune diseases needing treatment within 2 years, severe allergies to pembrolizumab components, certain infections or immunodeficiencies.Check my eligibility
What is being tested?
The study tests OT-101 combined with pembrolizumab in patients whose mesothelioma has progressed after checkpoint inhibitor therapy. It aims to evaluate the effectiveness and safety of various doses of OT-101 (a TGF-b2 inhibitor) alongside pembrolizumab.See study design
What are the potential side effects?
Potential side effects may include immune-related reactions due to pembrolizumab such as inflammation in organs like lungs (pneumonitis), skin issues, colitis; plus any unknown risks from OT-101 which targets TGF-b2 involved in cell growth.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I am 18 or older with a confirmed diagnosis of Malignant Pleural Mesothelioma.
Select...
My cancer progressed despite treatment with specific immune therapies.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determination of ORR for the combination of OT-101 and pembrolizumab in subjects
Secondary outcome measures
PFS, DOR and 6-month and 12-month Overall Survival (OS) will be estimated in all subjects in the ITT population.
Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
1Treatment groups
Experimental Treatment
Group I: Drug OT-101 plus pembrolizumabExperimental Treatment1 Intervention
OT-101 will be administered at a RP2D dose/m2/day for 4 days continuously and 10 days off every two weeks via a portable infusion pump.
Pembrolizumab will be administered with the standard regimen of 400 mg intravenously (IV) every six weeks.
Find a Location
Who is running the clinical trial?
Oncotelic Inc.Lead Sponsor
2 Previous Clinical Trials
473 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or restricted in physically strenuous activity but can do light work.You have a severe allergic reaction to pembrolizumab or any of the substances it contains.I have not received a live vaccine in the last 30 days.I am 18 or older with a confirmed diagnosis of Malignant Pleural Mesothelioma.I can provide a tissue sample from my tumor before starting treatment.I haven't had any cancer treatment or experimental drugs in the last 28 days.My cancer progressed despite treatment with specific immune therapies.I have active brain metastases or cancer in the lining of my brain.I have an immune system disorder or take more than 10 mg of steroids daily.I agree to use contraception and not donate sperm for 90 days after treatment.I am not pregnant or breastfeeding and will follow birth control advice for 90 days after treatment.I have an autoimmune disease treated with medication in the last 2 years.I have no health issues that could affect the study's results.I had another cancer but have been cancer-free for 2 years after treatment.I had radiotherapy less than 2 weeks before starting the study treatment.I have or had lung inflammation that needed steroids.My organs are functioning well, tested within the last 10 days.A woman who is able to have a baby and has a positive urine pregnancy test within 72 hours before taking the study drug.I am currently being treated for an infection.I have a history of Hepatitis B or active Hepatitis C.I have received an organ or tissue transplant from another person.You have a disease that can be measured using a specific method called Revised mRECIST.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Drug OT-101 plus pembrolizumab
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA given its okay to use OT-101?
"The safety of OT-101 was rated a 2."
Answered by AI
Are people with the required medical condition able to enroll in this trial at this time?
"The clinical trial noted on clinicaltrials.gov is not currently looking for participants, but this may change in the future. The listing was first posted on December 1st, 2020 and was updated June 16th, 2020. Additionally, there are 158 other trials that are actively recruiting patients right now."
Answered by AI
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