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TransCon IL-2 β/γ + Pembrolizumab/Chemotherapy for Solid Tumor Cancers (IL Believe Trial)
IL Believe Trial Summary
This trial is testing a new drug, TransCon IL-2 β/γ, to treat various solid tumors. The trial will test how well the drug works and what side effects it may have.
IL Believe Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowIL Believe Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.IL Believe Trial Design
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Who is running the clinical trial?
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- My organs are functioning well according to recent tests.I have a serious heart condition.My heart's electrical cycle is longer than usual.My cancer is advanced and cannot be cured with surgery or radiation, except as part of initial treatment.I am not on immunosuppressive treatment, except for a corticosteroid taper.I had immunotherapy and any side effects are now mild or gone, except for those controlled by hormone replacement.I have an autoimmune disease but it's under control with hormone therapy.I can care for myself and am up and about more than 50% of my waking hours.I have had treatments with IL-2 or TLR agonists for my cancer.I am currently breastfeeding or have tested positive for pregnancy.My cancer can be entirely removed with surgery.I have not received any live vaccines in the last 4 weeks.I am HIV positive or have an active hepatitis B or C infection.I am fully active or restricted in physically strenuous activity but can do light work.I have not had any other cancers in the last 2 years.I haven't had cancer treatment or radiation in the last 4 weeks.I agree to use effective birth control if I can have children.I've had a 4-week break from certain cancer treatments and my cancer has progressed.I do not have any untreated infections.I am 18 years old or older.I have symptoms from cancer spread to my brain or its coverings.
- Group 1: Part 3 Combination Dose Expansion
- Group 2: Part 4 Combination Dose Optimization
- Group 3: Part 3 Combination Dose Expansion:TransCon IL-2 β/γ + Pembrolizumab + SOC Chemo followed by surgery
- Group 4: Part 3 Combination Dose Expansion:TransCon IL-2 β/γ with TransCon TLR7/8 Agonist followed by surgery
- Group 5: Part 2 Combination Dose Escalation: TransCon IL-2 β/γ with Pembrolizumab
- Group 6: Part 3 Combination Dose Expansion: TransCon IL-2 β/γ with SOC Chemo
- Group 7: Part 3 Combination Dose Expansion: TransCon IL-2 β/γ with TransCon TLR7/8 Agonist
- Group 8: Part 3 Monotherapy Dose Expansion: TransCon IL-2 β/γ followed by surgery
- Group 9: Part 3 Combination Dose Expansion: TransCon IL-2 β/γ with Pembrolizumab followed by surgery
- Group 10: Part 1 Monotherapy Dose Escalation: TransCon IL-2 β/γ
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What are the previous findings regarding this Chemotherapy medication?
"City of Hope first conducted research on this chemotherapy drug in 2010. In the decade since, there have been 348 completed trials and presently 1000 active ones. A majority of these latter studies are based in Huntersville, North carolina."
Are we still looking for more participants for this clinical trial?
"That is correct. The online clinicaltrials.gov registry shows that this research project, which was first advertised on 1/11/2022, is still looking for participants. There are 5 different enrolling locations and the goal is to have 317 people enrolled in total."
What is the maximum patient limit for this clinical trial?
"The listing on clinicaltrials.gov reveals that this research is actively looking for participants. The study was made public on 1/11/2022, with the most recent update being 11/16/2022. They are currently 317 patients needed between 5 sites."
Why was this clinical trial originally designed and what benefits are researchers hoping to achieve?
"The primary outcome measure for this study, which will be observed over the course of 12 months, is safety and tolerability. Additionally, researchers will secondary outcomes including pathologic complete response, pharmacokinetic characterization, and event-free survival."
Across how many states is this research being conducted?
"Choosing a location for this clinical trial that is nearest to you is ideal, as there are currently 5 sites running the study and travel might be demanding. The locations of these trials are in Huntersville, Canton, Cincinnati and other places."
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