← 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 below
Select...
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 weeks
Treatment ~ Varies
Follow Up ~two years
This trial's timeline: 3 weeks for screening, Varies for treatment, and two years for reporting.

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 more

Side effects data

From 2020 Phase 2 trial • 44 Patients • NCT03250273
92%
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
13,928 Previous Clinical Trials
41,017,931 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

Bintrafusp Alfa (Immunotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04708470 — Phase 1 & 2
Anal Cancer Research Study Groups: 1/Arm 1, 3/Arm3, 2/Arm 2
Anal Cancer Clinical Trial 2023: Bintrafusp Alfa Highlights & Side Effects. Trial Name: NCT04708470 — Phase 1 & 2
Bintrafusp Alfa (Immunotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04708470 — Phase 1 & 2
~26 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top