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Cancer Vaccine

Retifanlimab for Colorectal Cancer

Phase 1
Waitlist Available
Led By Nilofer Azad, MD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights

Study Summary

This trial is testing a new cancer vaccine combined with an immunotherapy drug to treat patients with metastatic colorectal cancer or pancreatic cancer.

Eligible Conditions
  • Colorectal Cancer
  • Pancreatic Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants experiencing study drug-related toxicities
Percentage of patients who receive at least one dose of personalized neoantigen vaccine
Secondary outcome measures
Disease Control Rate (DCR)
Objective Response Rate (ORR) per RECIST 1.1
Objective Response Rate (ORR) per iRECIST
+3 more

Side effects data

From 2021 Phase 2 trial • 94 Patients • NCT03597295
23%
Asthenia
21%
Diarrhoea
18%
Fatigue
16%
Nausea
16%
Anaemia
15%
Vomiting
13%
Constipation
13%
Decreased appetite
12%
Pruritus
12%
Cough
12%
Dyspnoea
11%
Pyrexia
10%
Rectal haemorrhage
10%
Hypothyroidism
9%
Arthralgia
9%
Back pain
9%
Headache
9%
Weight decreased
7%
Urinary tract infection
7%
Proctalgia
7%
Aspartate aminotransferase increased
7%
Abdominal pain
6%
Insomnia
5%
Hypokalaemia
5%
Rash
5%
Cystitis
3%
General physical health deterioration
3%
Pelvic pain
2%
Inadequate analgesia
2%
Intestinal obstruction
2%
Hypercalcaemia
2%
Haematuria
2%
Pleural effusion
2%
Sepsis
2%
Pneumonia
1%
Purpura
1%
Acute kidney injury
1%
Flank pain
1%
Large intestinal obstruction
1%
Hydronephrosis
1%
Adrenal insufficiency
1%
Gastroenteritis
1%
Pancreatic carcinoma
1%
Respiratory failure
1%
Pain
1%
Proctitis haemorrhagic
1%
Immune-mediated enterocolitis
1%
Interstitial lung disease
1%
Pseudomonas infection
1%
Anal abscess
1%
Ileus
1%
Mental status changes
1%
Acute respiratory failure
1%
Cholecystitis acute
1%
Lyme disease
1%
Lymphangiosis carcinomatosa
1%
Herpes zoster
1%
Hepatitis
1%
Pelvic infection
1%
Peritonitis
1%
Blood bilirubin increased
1%
Body temperature increased
1%
Bone pain
1%
Cellulitis
1%
Cholangitis
1%
Cholecystitis
1%
Cognitive disorder
1%
Colonic fistula
1%
Coma hepatic
1%
Dehydration
1%
Device related infection
1%
Diffuse large B-cell lymphoma
1%
Fall
1%
Femur fracture
1%
Gastric ulcer
1%
Skin infection
1%
Stoma site infection
1%
Superior mesenteric artery syndrome
1%
Thrombosis
1%
Transitional cell carcinoma
1%
Tumour embolism
1%
Tumour pain
1%
Ureteric compression
1%
Urinary retention
1%
Venous thrombosis limb
1%
Pulmonary embolism
1%
Catheter site pain
1%
Pneumocystis jirovecii pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Retifanlimab 500 mg

Trial Design

1Treatment groups
Experimental Treatment
Group I: Neoantigen Vaccine with Poly-ICLC adjuvant and RetifanlimabExperimental Treatment2 Interventions
All participants receive this intervention.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Retifanlimab
2018
Completed Phase 2
~320

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
557 Previous Clinical Trials
32,900 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,521 Total Patients Enrolled
Incyte CorporationIndustry Sponsor
364 Previous Clinical Trials
55,165 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the size of the participant pool for this research?

"At this juncture, the trial is not currently enrolling participants; it was first submitted to clinicaltrials.gov on January 1st 2023 and last updated August 5th 2022. If you are in search of other studies, there are presently 3641 ongoing trials with metastatic colorectal cancer (crc) patients, as well as 26 Recifanlimab related investigations looking for enrollees."

Answered by AI

Has Retifanlimab received the green light from federal health authorities?

"As this is primarily a Phase 1 trial, meaning there has been limited data to evaluate the safety and efficacy of Retifanlimab, we at Power rate it as a 1."

Answered by AI

Are there any other trials in progress that involve Retifanlimab?

"Currently, there are 26 trails investigating the efficacy of Retifanlimab with 3 in Phase 3. Among them are two in A CORU�A and Virginia respectively; however 810 sites across the globe have launched studies into Retifanlimab's medicinal applications."

Answered by AI

Is this particular clinical trial a pioneering occurrence?

"Research into Retifanlimab began in 2016, when Incyte Corporation sponsored a clinical trial with 325 participants. This led to the drug's Phase 1 approval and presently there are 26 active trials for it across 117 cities and 43 countries."

Answered by AI

Is the recruitment period for this experiment still open?

"At the moment, this medical investigation is unable to accept patients. It was first advertised on January 1st 2023 and last updated on August 5th 2022. For those eager to join a study, there are currently 3641 trials recruiting for metastatic colorectal cancer (crc) and 26 studies welcoming participants with Retifanlimab."

Answered by AI

What are the goals of this research endeavor?

"According to Incyte Corporation, the primary endpoint of this trial will be measured over a two year period and is Percentage of patients who receive at least one dose of personalized neoantigen vaccine. Assessing other outcomes such as Overall Survival (OS), Objective Response Rate (ORR) per RECIST 1.1, and Progression-free Survival (PFS) per RECIST 1.1 are also part of the secondary objectives in which OS is defined as the number of months from date of first personalized vaccine dose until death or end of follow-up; ORR is determined by the number achieving CR or PR based on Response Evaluation"

Answered by AI
~0 spots leftby Apr 2025