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Nivolumab + DAY101 for Craniopharyngioma (PNOC029 Trial)
Phase 2
Recruiting
Led By Sabine Mueller, MD, PhD, MAS
Research Sponsored by Sabine Mueller, MD, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new combination therapy for the treatment of children and young adults with craniopharyngioma.
Who is the study for?
This trial is for children and young adults aged 1 to 39 with craniopharyngioma, who can undergo surgery. They should not have had certain treatments recently, must be able to provide tissue samples, and have good organ function. Pregnant or breastfeeding women are excluded, as well as those with immune disorders or severe cardiovascular issues.
What is being tested?
The study tests the safety and effectiveness of combining Nivolumab (a PD-1 inhibitor) with DAY101 (a pan-RAF kinase inhibitor) in treating craniopharyngioma. It's designed for patients who may be newly diagnosed or have recurrent disease after prior treatments.
What are the potential side effects?
Potential side effects include immune-related reactions like inflammation in various organs, skin rashes such as Stevens-Johnson syndrome, vision problems like retinal vein occlusion, liver enzyme changes indicating liver damage, fatigue, digestive issues and possible increased risk of infections.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Changes in scores on the Physical functioning subscale of the Pediatric Quality of Life Inventory (PedsQL) over time
Progression free survival rate (PFS)
Secondary study objectives
Attention Deficit Disorder
Proportion of participants with visual deficits over time
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
7Treatment groups
Experimental Treatment
Group I: Group 2, Arm D: Non-biopsy/resection participantsExperimental Treatment2 Interventions
Non-biopsy/resection participants with recurrent disease will receive combination maintenance therapy of nivolumab given every 2 weeks and Tovorafenib once weekly at the respected RP2D for each agent.
Group II: Group 2, Arm C: Neoadjuvant combination nivolumab and TovorafenibExperimental Treatment2 Interventions
Participants with recurrent craniopharyngioma will receive one (1) dose of nivolumab (14 days -5 days prior) and one (1) dose of Tovorafenib (7 days +/- 2 days) prior to planned biopsy or resection. At completion of biopsy or resection, participants having undergone biopsy only or STR or NTR will continue on combination maintenance therapy of nivolumab given every 2 weeks and Tovorafenib once weekly at the respected RP2D for each agent.
Group III: Group 2, Arm B: Neoadjuvant TovorafenibExperimental Treatment2 Interventions
Participants with recurrent craniopharyngioma will receive one (1) dose of Tovorafenib within 7 days +/- 2 days prior to planned biopsy or resection. At completion of biopsy or resection, participants having undergone biopsy only or STR or NTR will continue on combination maintenance therapy of nivolumab given every 2 weeks and Tovorafenib once weekly at the respected RP2D for each agent.
Group IV: Group 2, Arm A: Neoadjuvant nivolumabExperimental Treatment1 Intervention
Participants with recurrent craniopharyngioma will receive one (1) dose of nivolumab within 14 days - 5 days prior to planned biopsy or resection. At completion of biopsy or resection, participants having undergone biopsy only or STR or NTR will continue on combination maintenance therapy of nivolumab given every 2 weeks and Tovorafenib once weekly at the respected RP2D for each agent. If participants are eligible based on archival tissue alone, these participants will go directly on to receive combination therapy only.
Group V: Group 1, Arm C: Neoadjuvant combination nivolumab and TovorafenibExperimental Treatment2 Interventions
Participants with newly diagnosed craniopharyngioma will receive one (1) dose of nivolumab (14 days -5 days prior) and one dose of Tovorafenib (7days +/- 2 days prior) to planned biopsy or resection. At completion of biopsy or resection, participants having undergone biopsy only or sub-total (STR) or near-total resection (NTR) will continue on combination maintenance therapy of nivolumab given every 2 weeks and Tovorafenib once weekly at the respected RP2D for each agent. Participants having undergone a gross total resection (GTR) will enter into follow-up only and will be part of the exploratory cohort.
Group VI: Group 1, Arm B: Neoadjuvant TovorafenibExperimental Treatment2 Interventions
Participants with newly diagnosed craniopharyngioma will receive one (1) dose of Tovorafenib within 7 days +/- 2 days prior to planned biopsy or resection. At completion of biopsy or resection, participants having undergone biopsy only or sub-total (STR) or near-total resection (NTR) will continue on combination maintenance therapy of nivolumab given every 2 weeks and Tovorafenib once weekly at the respected RP2D for each agent . Participants having undergone a gross total resection (GTR) will enter into follow-up only and will be part of the exploratory cohort.
Group VII: Group 1, Arm A: Neoadjuvant nivolumabExperimental Treatment1 Intervention
Participants with newly diagnosed craniopharyngioma will receive one (1) dose of nivolumab within 14 days - 5 days prior to planned biopsy or resection. At completion of biopsy or resection, participants having undergone biopsy only or sub-total (STR) or near-total resection (NTR) will continue on combination maintenance therapy of nivolumab given every 2 weeks and Tovorafenib once weekly at the respected recommended phase 2 dose (RP2D) for each agent. Participants having undergone a gross total resection (GTR) will enter into follow-up only and will be part of the exploratory cohort.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2015
Completed Phase 3
~4010
Find a Location
Who is running the clinical trial?
Day One Biopharmaceuticals, Inc.Industry Sponsor
6 Previous Clinical Trials
834 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,688 Previous Clinical Trials
4,096,751 Total Patients Enrolled
Sabine Mueller, MD, PhDLead Sponsor
8 Previous Clinical Trials
379 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1, Arm C: Neoadjuvant combination nivolumab and Tovorafenib
- Group 2: Group 2, Arm A: Neoadjuvant nivolumab
- Group 3: Group 2, Arm D: Non-biopsy/resection participants
- Group 4: Group 1, Arm A: Neoadjuvant nivolumab
- Group 5: Group 1, Arm B: Neoadjuvant Tovorafenib
- Group 6: Group 2, Arm C: Neoadjuvant combination nivolumab and Tovorafenib
- Group 7: Group 2, Arm B: Neoadjuvant Tovorafenib
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