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Combination Immunotherapy for Human Papillomavirus & Colorectal Cancer
Study Summary
This trial is testing a new combination drug treatment for people with metastatic HPV-associated cancers or microsatellite stable small bowel or colorectal cancer.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- My kidney and liver are functioning well.I use steroids only in forms that don't significantly affect my whole body.I have not had major surgery in the last 28 days.I have cervical cancer.My condition is anal cancer.My kidney function, measured by creatinine clearance, is good.I need regular procedures to remove excess fluid from my body due to my condition.I am not on high-dose steroids or other drugs that suppress my immune system.I do not have serious ongoing health issues like heart, lung, or liver diseases.I have advanced cancer that didn't respond to checkpoint inhibitors and is linked to HPV, or I have MSS small bowel/colorectal cancer.My cancer is in the vulva, vagina, penis, or rectum.I am using or willing to use effective birth control during and after the trial.I have HIV or Hepatitis with undetectable viral loads and stable health.I haven't had cancer treatments except for palliative bone therapy in the last 28 days, or any side effects are mild.I have had a severe allergic reaction to drugs similar to the study drugs.I have colorectal or small bowel cancer and have had two prior chemotherapy treatments, or I have HPV-related cancer and have had one chemotherapy and approved checkpoint therapy.I am not pregnant or breastfeeding.You have an autoimmune disease that could get worse if you take a drug that boosts your immune system, unless specific conditions apply.I have a mild autoimmune disorder like diabetes type I or eczema, not needing strong medication.My cancer is HPV positive and has spread beyond its original location.My throat cancer is P16 positive.I have HPV-related cancer and it got worse after anti PD-1(L1) therapy.I am 18 years old or older.My liver tests are within normal limits, unless I have liver cancer spread.My brain or CNS cancer has been stable for over a month after treatment, and I'm on low-dose steroids or have no significant recent bleeding.I have advanced or metastatic cancer linked to HPV, or MSS small bowel/colorectal cancer.I haven't had cancer, except for certain types, in the last 3 years.I can do most of my daily activities without help.I have not received a live vaccine in the last 30 days.I haven't had ulcers, organ failure, or bowel disease in the last 6 months.
- Group 1: 1/Arm 1
- Group 2: 3/Arm3
- Group 3: 2/Arm 2
- 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 goals of this clinical trial?
"The primary outcome of this trial is the Objective Response Rate (ORR) of triple combination therapy, which will be evaluated over a period of approximately two years. Secondary objectives include Progression-Free Survival (PFS) and Duration of Response (DoR), as well as the safety of Triple Combination Therapy."
Does this experimental treatment have a history?
"As of right now, there are 39 different ongoing clinical trials that are studying NHS-IL12. Out of these investigations, 4 of them have reached Phase 3. Most of the research for NHS-IL12 is being conducted in Amsterdam, but locations all over the world are participating in studies related to this topic."
Are we still able to enroll new patients in this trial?
"Yes, this study is still recruiting participants. The clinicaltrials.gov website reports that the trial was first posted on October 5th, 2021 and last updated on November 11th, 2022."
How many people will be able to join this experiment?
"That is correct. As of right now, the clinical trial mentioned is actively searching for patients to enroll. The study was first posted on October 5th, 2021 and was last updated on November 11th, 2022. They are looking for 80 individuals total at 1 location."
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