Your session is about to expire
← Back to Search
Checkpoint Inhibitor
TILT-123 + Pembrolizumab for Ovarian Cancer (PROTA Trial)
Phase 1
Recruiting
Research Sponsored by TILT Biotherapeutics Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female over 18 years of age on day of signing informed consent(s).
At least one tumor (>14 mm in diameter) or carcinomatosis must be available for local virus injection (intratumoral and/or intraperitoneal).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 92
Awards & highlights
PROTA Trial Summary
This trial is testing a new cancer treatment that uses a virus to kill cancer cells. The treatment is being given to patients with ovarian cancer that has not responded to other treatments.
Who is the study for?
This trial is for women over 18 with ovarian cancer that's resistant to platinum treatment and can't be cured with existing therapies. Participants must have a tumor or carcinomatosis suitable for direct virus injection, good organ function, agree to contraception use, an ECOG/WHO score of 0-1, and a life expectancy over 3 months.Check my eligibility
What is being tested?
The trial tests the safety of TILT-123 (an oncolytic adenovirus) combined with Pembrolizumab in patients with advanced ovarian cancer. It's an early-phase study where doses increase gradually to find safe levels. Patients receive both treatments directly into tumors or the abdominal cavity.See study design
What are the potential side effects?
Potential side effects include typical immune therapy reactions like inflammation in various organs, infusion-related symptoms, fatigue, possible autoimmune disease flare-ups if predisposed, and infection risks due to immune system modulation by Pembrolizumab.
PROTA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman over 18 and can sign a consent form.
Select...
I have a tumor larger than 14 mm or carcinomatosis suitable for direct virus injection.
Select...
My ovarian cancer does not respond to platinum treatments and cannot be cured with current therapies.
Select...
I am fully active or can carry out light work.
PROTA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 92
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 92
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants with Adverse Events assessed by electrocardiograms (ECGs)
Number of Participants with abnormal laboratory values
Number of Participants with any (serious and non-serious) Adverse Events
+1 moreSide 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
PROTA Trial Design
1Treatment groups
Experimental Treatment
Group I: TILT-123 and pembrolizumabExperimental Treatment2 Interventions
Patients will receive multiple administrations of TILT-123 and pembrolizumab.
Escalation to the next dose of TILT-123 level will occur when the safety data has been evaluated for all patients in the preceding dose level.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
pembrolizumab
2017
Completed Phase 3
~5750
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
3,892 Previous Clinical Trials
5,060,642 Total Patients Enrolled
TILT Biotherapeutics Ltd.Lead Sponsor
4 Previous Clinical Trials
72 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer can be measured or observed but doesn't need to meet specific criteria.I haven't had cancer treatment in the last 30 days.I have an immune system disorder or have been on steroids recently.My organs are functioning well.I don't have any health issues that could affect the study's results.I am a woman over 18 and can sign a consent form.I have had pneumonitis treated with steroids or have it now.I have received an organ or tissue transplant from another person.I have been treated for an autoimmune disease in the last 2 years.I am currently being treated for an infection.I have a history of hepatitis B, hepatitis C, or HIV.I am allergic or react badly to pembrolizumab.I have not had radiotherapy in the last 2 weeks.I have a tumor larger than 14 mm or carcinomatosis suitable for direct virus injection.I have not received a live vaccine in the last 30 days.I stopped a cancer treatment due to severe side effects.My ovarian cancer does not respond to platinum treatments and cannot be cured with current therapies.I understand and can follow the study's requirements.You are expected to live for more than 3 months.My cancer has spread to my brain or its coverings.I do not have any uncontrolled heart or blood vessel problems.I haven't had a heart attack or stroke in the last year, or I've fully recovered from one.I am fully active or can carry out light work.I have another cancer that is growing or was treated in the last 5 years.I have recovered from side effects of previous treatments to my normal or mild condition.I have a history of blood clotting issues.I am not pregnant, breastfeeding, nor planning to become pregnant.I have had serious liver problems.
Research Study Groups:
This trial has the following groups:- Group 1: TILT-123 and pembrolizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA signed off on TILT-123?
"The safety of TILT-123 is assessed at 1 due to its status as a Phase 1 trial, which indicates limited evidence for both efficacy and protection."
Answered by AI
What is the current enrollment of this research endeavor?
"Affirmative. Clinicaltrials.gov indicates that this experiment is actively seeking participants, having been posted on May 17th 2022 and last modified October 17th 2022. In total, 15 patients need to be recruited for the trial at a single site."
Answered by AI
Is this clinical trial taking on new participants at the present time?
"This clinical trial is still open for enrolment, as indicated on the website. It was initially made available to participants on May 17th 2022 and has undergone an edit since then, last updated in October of this year."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger