Your session is about to expire
← Back to Search
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).
Must not have
Major surgery within 28 days prior to enrollment (minimally invasive procedures such as diagnostic biopsies are permitted).
Presence of medically significant third space fluid (symptomatic pericardial effusion, ascites or pleural effusion requiring repetitive paracentesis).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up two years
Awards & highlights
No Placebo-Only Group
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not had major surgery in the last 28 days.
Select...
I need regular procedures to remove excess fluid from my body due to my condition.
Select...
I am not pregnant or breastfeeding.
Select...
I haven't had ulcers, organ failure, or bowel disease in the last 6 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ two years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Determine RP2D of entinostat
Ojective response rate (ORR) of triple combination
Secondary study objectives
Duration of Response (DoR)
Hospitalization due to AEs attributed to PD
Progression-Free Survival (PFS)
+1 moreSide effects data
From 2020 Phase 2 trial • 44 Patients • NCT0325027392%
Fatigue
46%
Nausea
38%
Anorexia
31%
Edema
23%
Platelet count decreased
23%
Rash maculo-papular
15%
Thrush
15%
Diarrhea
15%
Constipation
15%
Pneumonitis
15%
Dysgeusia
8%
Neutrophil count decreased
8%
White blood cell decreased
8%
Hypothyroidism
8%
Fever
8%
Pneumonia
8%
Dry lips
8%
Hyponatremia
8%
Anemia
8%
Transaminitis
8%
Early satiety
8%
Flu-like symptoms
8%
Lymphocyte count decreased
8%
Dizziness
8%
Colitis
8%
Aspartate aminotransferase increased
8%
Insomnia
8%
Pruritus
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A - Cholangiocarcinoma
ARM B - Pancreatic Cancer
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: 3/Arm3Experimental Treatment2 Interventions
Entinostat and PDS01ADC (without bintrafusp alfa)
Group II: 2/Arm 2Experimental Treatment3 Interventions
RP2D of entinostat, PDS01ADC, and bintrafusp alfa
Group III: 1/Arm 1Experimental Treatment3 Interventions
Dose escalation/de-escalation of entinostat and dose escalation of PDS01ADC with fixed dose of bintrafusp alfa
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bintrafusp Alfa
2018
Completed Phase 2
~90
Entinostat
2017
Completed Phase 2
~1320
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,917 Previous Clinical Trials
41,014,358 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.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger