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Cemiplimab for Head and Neck Squamous Cell Carcinoma (MINIMA Trial)
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.
MINIMA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowMINIMA Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2023 Phase 3 trial • 608 Patients • NCT03257267MINIMA Trial Design
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Who is running the clinical trial?
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- I have an active case of tuberculosis.I have not had radiation or chemotherapy for head or neck cancer.I can carry out all my daily activities without help.My cancer has spread to distant parts of my body.I have an autoimmune disease that needed treatment in the last year.My HPV test results meet specific criteria, including being p16 positive.I haven't had any cancer treatment in the last 8 weeks.I have an immune system disorder or am on medication that weakens my immune system.My cancer is HPV-positive and located in my head, neck, or oropharynx.I have mild or no nerve damage.I have another cancer that is getting worse or needs treatment.My organ functions are within normal ranges.I have a history of HIV or active Hepatitis B or C.The origin of my cancer is unknown.I have had surgery for my condition, but not the ones specifically listed.I have a history of or currently have non-infectious lung inflammation.I have not received a live vaccine in the last 28 days.I am 18 or older and my cancer stage fits specific criteria.I agree to use contraception if I am sexually active with women who can become pregnant.
- Group 1: De-Escalated Therapy
- Group 2: Non/Minimally De-Escalated Therapy
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
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."
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."
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."
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."
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."
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."
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