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Immunotherapy
Combination Immunotherapy for Human Papillomavirus & Colorectal Cancer
Phase 1 & 2
Recruiting
Led By Jason M Redman, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
- Measured or calculated creatinine clearance (using the Cockcroft-Gault equation) > 50 mL/min
Phase II: Subjects with cytologically or histologically confirmed locally advanced or metastatic checkpoint refractory HPV associated malignancies (Cohort 2), or MSS small bowel or colorectal cancer (Cohort 3).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up two years
Awards & highlights
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.
Who is the study for?
Adults 18+ with advanced or metastatic HPV-associated cancers (like cervical, anal, vulvar) or microsatellite stable small bowel/colorectal cancer. Must have had prior chemotherapy and be HIV/Hep B/C positive with undetectable viral loads. Participants need good blood counts, organ function, and must use effective contraception.Check my eligibility
What is being tested?
The trial is testing a combination of three drugs: Bintrafusp Alfa (IV every 2 weeks), NHS-IL12 (injection every 4 weeks), and Entinostat (oral once a week). The goal is to find safe doses that may shrink tumors in patients with certain advanced cancers over treatment cycles lasting up to two years.See study design
What are the potential side effects?
Potential side effects include reactions at the injection site, immune system-related inflammation affecting various organs, fatigue, changes in liver enzymes indicating liver stress, possible impact on blood cell counts leading to increased infection risk or bleeding tendencies.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function, measured by creatinine clearance, is good.
Select...
I have advanced cancer that didn't respond to checkpoint inhibitors and is linked to HPV, or I have MSS small bowel/colorectal cancer.
Select...
My cancer is in the vulva, vagina, penis, or rectum.
Select...
I have HIV or Hepatitis with undetectable viral loads and stable health.
Select...
My cancer is HPV positive and has spread beyond its original location.
Select...
My throat cancer is P16 positive.
Select...
I am 18 years old or older.
Select...
I can do most of my daily activities without help.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ two years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine RP2D of entinostat
Ojective response rate (ORR) of triple combination
Secondary outcome measures
Duration of Response (DoR)
Hospitalization due to AEs attributed to PD
Progression-Free Survival (PFS)
+1 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: 3/Arm3Experimental Treatment2 Interventions
Entinostat and NHS-IL12 (without bintrafusp alfa)
Group II: 2/Arm 2Experimental Treatment3 Interventions
RP2D of entinostat, NHS-IL12, and bintrafusp alfa
Group III: 1/Arm 1Experimental Treatment3 Interventions
Dose escalation/de-escalation of entinostat and dose escalation of NHS-IL12 with fixed dose of bintrafusp alfa
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bintrafusp Alfa
2021
Completed Phase 2
~40
Entinostat
2017
Completed Phase 2
~1170
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,670 Previous Clinical Trials
40,926,629 Total Patients Enrolled
Jason M Redman, M.D.Principal InvestigatorNational Cancer Institute (NCI)
4 Previous Clinical Trials
176 Total Patients Enrolled
Julius Y Strauss, M.D.Principal InvestigatorNational Cancer Institute (NCI)
5 Previous Clinical Trials
181 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: 1/Arm 1
- Group 2: 3/Arm3
- Group 3: 2/Arm 2
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.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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