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PD-1 Inhibitor

Cemiplimab for Head and Neck Squamous Cell Carcinoma (MINIMA Trial)

Phase 2
Recruiting
Led By Tanguy Seiwert, M.D.
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
No previous radiation or chemotherapy for a head and neck cancer.
ECOG performance status 0-1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

MINIMA Trial Summary

This trial is testing whether using immunotherapy as part of treatment for pancreatic cancer can reduce treatment intensity and improve long-term quality of life while maintaining high cure rates.

Who is the study for?
Adults with HPV-positive head and neck squamous cell carcinoma, specifically without distant metastases or prior major treatments for the cancer. Participants must have good organ function, not be pregnant or breastfeeding, and agree to use contraception. Those with active infections, other cancers needing treatment, significant heart problems, or immune system issues are excluded.Check my eligibility
What is being tested?
The trial is testing Cemiplimab alone or combined with chemotherapy in patients before surgery to see if it can reduce the intensity of later treatments while maintaining high cure rates. The goal is also to improve long-term quality of life for these patients.See study design
What are the potential side effects?
Cemiplimab may cause immune-related side effects such as inflammation in various organs, skin reactions, fatigue, potential hormonal changes (like thyroid dysfunction), and increased risk of infection due to its action on the immune system.

MINIMA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have not had radiation or chemotherapy for head or neck cancer.
Select...
I can carry out all my daily activities without help.
Select...
My HPV test results meet specific criteria, including being p16 positive.
Select...
My organ functions are within normal ranges.
Select...
I am 18 or older and my cancer stage fits specific criteria.

MINIMA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the date of registration to the date of death or date of last follow-up, up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of registration to the date of death or date of last follow-up, up to 2 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
2-year progression free survival rate
Change in Quality of life as measured by MD Anderson Dysphagia Inventory (MDADI)
Change in quality of life as measured by the Sydney Swallow Questionnaire (SSQ).
+2 more
Secondary outcome measures
Number of grade 3 Immune-related adverse events (irAE)
Number of grade 3 toxicities
Number of grade 4 Immune-related adverse events (irAE)
+3 more
Other outcome measures
HPV ctDNA Clearance
Rate of Induction Tumor/HPV
To interrogate the immune micro-environment at baseline, and 3 weeks into induction therapy with cemiplimab and chemotherapy based on an on-treatment biopsy

Side effects data

From 2023 Phase 3 trial • 608 Patients • NCT03257267
25%
Anaemia
20%
Nausea
17%
Fatigue
16%
Vomiting
15%
Decreased appetite
15%
Constipation
11%
Asthenia
11%
Back pain
11%
Pyrexia
11%
Diarrhoea
10%
Arthralgia
9%
Urinary tract infection
9%
Dyspnoea
9%
Abdominal pain
7%
Cough
7%
Oedema peripheral
7%
Hypoalbuminaemia
7%
Headache
6%
Pain in extremity
6%
Rash
6%
Blood creatinine increased
6%
Insomnia
6%
Hypokalaemia
6%
Hypothyroidism
5%
Pruritus
5%
Vaginal haemorrhage
4%
Alanine aminotransferase increased
4%
Aspartate aminotransferase increased
4%
Pelvic pain
4%
Stomatitis
3%
Neutropenia
2%
Acute kidney injury
1%
Febrile neutropenia
1%
Pneumonia
1%
Pyelonephritis
1%
Autoimmune hepatitis
1%
Immune-mediated hepatitis
1%
Thrombocytopenia
1%
Neutrophil count decreased
1%
Pyelonephritis acute
1%
White blood cell count decreased
1%
Sepsis
1%
Duodenal ulcer
1%
Haematuria
1%
Hydronephrosis
1%
Hyperpyrexia
1%
Kidney infection
1%
Pneumonitis
1%
Hyperglycaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cemiplimab
Investigator Choice (IC) Chemotherapy

MINIMA Trial Design

2Treatment groups
Experimental Treatment
Group I: Non/Minimally De-Escalated TherapyExperimental Treatment1 Intervention
Surgery + Post-Operative Radiation Therapy (PORT) or 60 Gy Chemo-Radiation Therapy (CRT)
Group II: De-Escalated TherapyExperimental Treatment1 Intervention
Surgery (TORS) or Low-dose Radiation Therapy (42 Gy)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cemiplimab
2015
Completed Phase 3
~1340

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
556 Previous Clinical Trials
32,848 Total Patients Enrolled
Regeneron PharmaceuticalsIndustry Sponsor
613 Previous Clinical Trials
379,713 Total Patients Enrolled
Tanguy Seiwert, M.D.Principal InvestigatorJohns Hopkins University/Sidney Kimmel Cancer Center
5 Previous Clinical Trials
211 Total Patients Enrolled

Media Library

Cemiplimab (PD-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04988074 — Phase 2
Squamous Cell Carcinoma Research Study Groups: De-Escalated Therapy, Non/Minimally De-Escalated Therapy
Squamous Cell Carcinoma Clinical Trial 2023: Cemiplimab Highlights & Side Effects. Trial Name: NCT04988074 — Phase 2
Cemiplimab (PD-1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04988074 — Phase 2

Frequently Asked Questions

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

Are there any existing studies that have explored the efficacy of Cemiplimab?

"Presently, there are 56 research initiatives focused on Cemiplimab with 4 of them in their third phase. Despite the majority of these trials being conducted out of Barcelona and California, a total of 1738 facilities worldwide have taken part in this study."

Answered by AI

What conditions can Cemiplimab be used to treat?

"Cemiplimab is a common remedy for the alk gene mutation, though this medication can also be used to treat more general conditions like advance directives and metastatic cutaneous squamous cell carcinoma."

Answered by AI

How many individuals have enrolled to participate in this experiment?

"Affirmative. Information available on clinicaltrials.gov reveals that this experiment is actively recruiting, with 32 participants sought from a single site since its inception on December 13th 2021 and most recent edit occurring January 10th 2022."

Answered by AI

Are there any opportunities to participate in this experiment currently available?

"Affirmative. According to the public listing on clinicaltrials.gov, this research study is presently enrolling participants - it was first posted on December 13th 2021 and amended most recently January 10th 2022. It requires 32 members from one medical site."

Answered by AI

What conclusions are researchers seeking to draw from this trial?

"This medical trial will measure the primary outcome, namely changes in swallow function as reported by the MD Anderson Dysphagia Inventory over a period of two years. Other objectives include enumerating grade 4 toxicities using CTCAE and determining locoregional/distant control for all participants through RECIST criteria 1.1; additionally, we'll count the number of Grade 4 Immune-related adverse events (irAE) with CTCAE's help."

Answered by AI

What potential risks is Cemiplimab associated with?

"Our researchers at Power rate Cemiplimab's safety as a 2, given it is still in Phase 2 and the data collected thus far has only demonstrated its security."

Answered by AI
~7 spots leftby Nov 2024