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Monoclonal Antibodies
T3011 + Pembrolizumab for Solid Cancers
Phase 1 & 2
Recruiting
Research Sponsored by ImmVira Pharma Co. Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Capable of understanding and complying with protocol requirements
Age 18 years or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years from first dose of t3011
Awards & highlights
Study Summary
This trial is testing a new cancer treatment to see if it is safe and effective.
Who is the study for?
Adults with advanced solid tumors who've had disease progression after standard treatments or are unlikely to benefit from them. They must have a tumor lesion suitable for injection, a life expectancy over 12 weeks, and agree to use contraception. Exclusions include pregnancy, certain allergies, active infections like COVID-19, recent vaccines, immunodeficiencies, organ transplants, some heart conditions.Check my eligibility
What is being tested?
The trial is testing T3011 alone and combined with pembrolizumab in patients with various advanced cancers. It's an early-phase study assessing safety and initial effectiveness of these treatments administered directly into the tumor (T3011) and intravenously (pembrolizumab).See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site for T3011, typical immune-related adverse events from pembrolizumab such as fatigue, skin rash or itching; digestive issues; lung inflammation; hormonal gland problems; muscle pain or weakness.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I understand and can follow the study's requirements.
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I am 18 years old or older.
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I am fully active or can carry out light work.
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My cancer has returned or spread and this was confirmed by a lab test.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years from first dose of t3011
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years from first dose of t3011
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Characterize the safety and tolerability of T3011 in combination with pembrolizumab
Characterize the safety and tolerability of T3011 in combination with pembrolizumab in participants who progress on T3011 alone
Safety and tolerability of T3011 dose(s) selected from Phase 1 in disease specific cohorts
+2 moreSecondary outcome measures
Disease control rate (DCR)
Durable response (DR)
Duration of response (DOR)
+5 moreTrial Design
5Treatment groups
Experimental Treatment
Group I: Rollover ArmExperimental Treatment1 Intervention
RP2D T3011 + pembrolizumab in participants who have progressed on T3011 single agent
Group II: Phase 2a Part 2 Arm CExperimental Treatment1 Intervention
RP2D T3011 + pembrolizumab in participants with NSCLC
Group III: Phase 2a Part 1 Arm BExperimental Treatment1 Intervention
RP2D T3011 single agent in participants with other solid tumors
Group IV: Phase 2a Part 1 Arm AExperimental Treatment1 Intervention
RP2D T3011 single agent in participants with melanoma
Group V: Phase 1Experimental Treatment1 Intervention
T3011 single agent dose escalation in participants with solid tumors
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Who is running the clinical trial?
ImmVira Pharma Co. LtdLead Sponsor
5 Previous Clinical Trials
468 Total Patients Enrolled
1 Trials studying Sarcoma
233 Patients Enrolled for Sarcoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have serious heart conditions like heart failure or unstable angina.I am allergic to certain virus-based therapies or immune system drugs.I am currently infected with COVID-19.I have a tumor that can be injected with treatment according to my doctor.I haven't had live or weakened vaccines in the last 4 weeks.I have or had cancer spread to my brain or spinal cord.I had a bad reaction to previous immunotherapy or developed lung issues from it.My organ functions are within normal ranges according to recent tests.I currently have an active herpes sore.You have an active infection of hepatitis B, hepatitis C, or HIV or a positive test for these viruses within 14 days before starting the study drug.You have a disease that can be measured using a specific set of guidelines.I haven't taken steroids or immunosuppressants in the last 4 weeks.I have or had lung inflammation treated with steroids.I have previously received treatments like tumor vaccines or gene therapy.My cancer has spread to more than 3 areas or my largest tumor is bigger than 3 cm (non-sarcoma)/5 cm (sarcoma).I need to keep taking medication for herpes.My condition worsened after standard treatment or is not expected to improve with it.I need treatment for fluid buildup in my chest or abdomen.I am willing to provide fresh tumor samples as needed.I understand and can follow the study's requirements.My tumor is pressing on major airways or blood vessels.My tumors cannot be treated with injections.You are expected to live for at least 12 more weeks.I am 18 years old or older.I have not had a seizure in the last 6 months.My previous radiation treatment included the area around my carotid artery.I have recovered from all side effects of my previous cancer treatments.It's been over 3 weeks since my last cancer treatment or surgery.You have a weakened immune system.I have signed the consent form for this study.I have had an organ transplant.I am fully active or can carry out light work.I have been treated with anti-PD-(L)1 and IL-12 before.My cancer has returned or spread and this was confirmed by a lab test.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1
- Group 2: Phase 2a Part 1 Arm A
- Group 3: Phase 2a Part 2 Arm C
- Group 4: Rollover Arm
- Group 5: Phase 2a Part 1 Arm B
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.
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.
If a patient wanted to enroll in this trial, could they?
"Currently, this study detailed on clinicaltrials.gov is recruiting participants. This information was first posted on September 17th, 2020 and last updated on October 28th, 2022."
Answered by AI
Is T3011 a common medication in research?
"T3011 was first used in 2010 in a clinical setting at City of Hope. So far, there have been 247 completed studies with T3011. Right now, 1000 medical trials are using this drug and recruiting patients; many of these trials are based in Boston, Massachusetts."
Answered by AI
How many test subjects are in this experiment?
"The trial needs a total of 64 patients that match the study's inclusion criteria. The sponsor, ImmVira Pharma Co. Ltd, will be conducting the trial at various locations; two notable sites are Massachusetts General Hospital in Boston and Banner MD Anderson Cancer Center in Gilbert, Arizona."
Answered by AI
How many different medical facilities are participating in this research project?
"The research team for this study is based out of Massachusetts General Hospital in Boston, with Banner MD Anderson Cancer Center in Gilbert, Arizona, and University of Pittsburgh Medical Center in Pittsburgh, Pennsylvania being some of the other sites. There are a total of 6 locations involved."
Answered by AI
What are the conditions that T3011 is most often effective against?
"T3011 is a medication that oncologists often prescribe to patients with malignant neoplasms. It can also help those struggling with conditions like unresectable melanoma and microsatellite instability high, especially when chemotherapy has failed to bring about disease progression."
Answered by AI
What are the benefits that this clinical trial is hoping to bring patients?
"The primary objective of this study, which will follow participants for a period of up to 2 years from their first dose of T3011, is to identify an effective dosage of the medication. Additionally, researchers will assess the disease control rate (DCR), durable response (DR), and progression-free survival (PFS) as secondary objectives."
Answered by AI
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