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Nivolumab + DAY101 for Craniopharyngioma (PNOC029 Trial)
PNOC029 Trial Summary
This trial is testing a new combination therapy for the treatment of children and young adults with craniopharyngioma.
PNOC029 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.PNOC029 Trial Design
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- I took my last growth factor shot more than 2 weeks ago if it was long-acting, or more than a week ago if it was short-acting.I have not received any treatment for my cancer yet.I do not have unmanaged symptoms from neuroendocrine issues.I still have visible signs of my disease while on maintenance therapy.I haven't had chemotherapy or radiotherapy recently.I do not need urgent surgery or radiation due to rapidly worsening symptoms.I am not currently ill with a condition that is not under control, nor am I participating in another clinical trial.It's been over 3 weeks since my last standard chemotherapy, or over 6 weeks if it was with nitrosoureas.I am not currently taking any medications that would exclude me from the trial.I have been newly diagnosed with craniopharyngioma based on imaging.I am eligible for surgery to remove or sample a piece of my tumor.I can attend all required follow-up visits.My major organs are functioning well.I do not have ongoing severe nausea, problems absorbing food, or major bowel/stomach surgery.I have not had pneumonitis or chest radiation in the last 5 years.My craniopharyngioma has come back and is confirmed by a biopsy.I can do most activities but may need help.It has been over 21 days since my last monoclonal antibody treatment.I am not pregnant or breastfeeding.I do not have active heart disease or a recent heart attack.I have a new diagnosis of craniopharyngioma confirmed by imaging and possibly biopsy.You must be willing to provide a small piece of tissue from your tumor for testing. The tissue should be at least 40% tumor content, or you can provide 10-20 unstained slides of the tissue. If you cannot meet this requirement, the study team may discuss your case individually.I took my last cancer medication more than a week ago.I am eligible for surgery to remove or sample a piece of my tumor.I have had surgery, radiation, or other treatments for my condition.I have a recurring craniopharyngioma confirmed by initial diagnosis.I am eligible for surgery to remove or biopsy my tumor, or I have existing tumor samples.
- 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.
- Group 1: Group 2, Arm D: Non-biopsy/resection participants
- Group 2: Group 1, Arm C: Neoadjuvant combination nivolumab and Tovorafenib
- Group 3: Group 2, Arm A: Neoadjuvant nivolumab
- Group 4: Group 1, Arm B: Neoadjuvant Tovorafenib
- Group 5: Group 2, Arm C: Neoadjuvant combination nivolumab and Tovorafenib
- Group 6: Group 1, Arm A: Neoadjuvant nivolumab
- Group 7: Group 2, Arm B: Neoadjuvant Tovorafenib
Frequently Asked Questions
Is eligibility for this research limited to individuals above fifty years of age?
"For this clinical trial, individuals must be over 1 year old but below the age of 39 to qualify."
Has the DAY101 drug been validated by the Food and Drug Administration?
"Our team at Power rated DAY101 a 2 on the safety scale, as its clinical trial is only in Phase 2 and data supporting efficacy has yet to be generated."
What is the current number of participants in this clinical experiment?
"Affirmative. According to the information posted on clinicaltrials.gov, this medical trial is still actively searching for participants and was first published on September 12th 2022. There are 56 openings across 2 sites with a final edit date of November 3rd 2022."
Is the research team still accepting volunteers for this investigation?
"Affirmative, the information provided on clinicaltrials.gov confirms that this research effort is recruiting participants. The study was first announced in September of 2022 and was last updated in November of 2022. There are 56 available slots across two enrolment sites."
Could I potentially qualify for participation in this investigation?
"This clinical trial seeks 56 participants diagnosed with craniopharyngioma, who are between the age of 1 and 39. To be eligible, they must fulfil various criteria such as being surgical candidates for biopsy or resection; providing adequate tissue samples (10-20 paraffin embedded unstained slides or a block containing 40% tumor content); having been newly diagnosed within 4 weeks prior to radiographic diagnosis; not receiving myelosuppressive chemotherapy in the last 21 days (>=42 days if nitrosourea therapy), hematopoietic growth factor in the past 14/7 days depending on its type,"
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