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Kinase Inhibitor
Subprotocol C2 (MET exon 14 deletion/mutation) for Head and Neck Cancers
Phase 2
Waitlist Available
Led By Keith T Flaherty
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have histologically documented solid tumors or histologically confirmed diagnosis of lymphoma or multiple myeloma requiring therapy and meet specific progression criteria
Tumor tissue for the confirmation of 'rare variant' by the MATCH assay is to be submitted, preferably from the same time of collection as that used to determine patient candidacy for treatment arm assignment
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upup to 3 years
Awards & highlights
No Placebo-Only Group
Study Summary
This trial uses genomic testing to direct cancer treatment. Patients with cancer that has progressed after standard treatment or for which there is no agreed-upon treatment may benefit.
Eligible Conditions
- Head and Neck Cancers
- Lung Cancer
- Lymphoma
- Cancer
- Bladder Cancer
- Breast Cancer
- Colorectal Cancer
- Melanoma
- Liver Cancer
- Multiple Myeloma
- Ovarian Cancer
- Pancreatic Cancer
- Prostate Cancer
- Brain Tumor
- Endometrial Cancer
- Solid Tumors
- Skin Cancer
- Thyroid Cancer
- Esophageal Cancer
- Stomach Cancer
- Kidney Cancer
- Cervical Cancer
- Uterine Cancer
- Gastric Cancer
- Rectal Cancer
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You have been diagnosed with a solid tumor, lymphoma, or multiple myeloma and need treatment for it.
Select...
You need to provide a sample of your tumor tissue to confirm a specific genetic variation using a special test.
Select...
You should be able to do most of your daily activities and have a life expectancy of at least 3 months.
Select...
People with HIV may be allowed to participate if they meet certain requirements.
Select...
Patients must have specific blood and body chemistry test results within a certain range.
Select...
You need to have had a heart test within 8 weeks before joining the study, and your heart needs to meet specific health standards.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective response rate
Secondary outcome measures
Overall survival
Progression free survival
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
38Treatment groups
Experimental Treatment
Group I: Subprotocol Z1M (LAG-3 expression >= 1%)Experimental Treatment4 Interventions
Patients receive nivolumab IV over 30 minutes and relatlimab IV over 30 minutes on day 1.Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group II: Subprotocol Z1L (BRAF fusion, aberration or non-V600 mutation)Experimental Treatment3 Interventions
Patients with a BRAF non-V600 mutation or BRAF fusion, or another BRAF aberration receive ulixertinib (BVD-523FB) PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group III: Subprotocol Z1K (AKT mutation)Experimental Treatment3 Interventions
Patients receive ipatasertib PO QD. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group IV: Subprotocol Z1I (BRCA1 or BRCA2 gene mutation)Experimental Treatment3 Interventions
Patients with BRCA1 or BRCA2 gene mutation receive adavosertib PO QD for 5 days for 2 weeks. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Group V: Subprotocol Z1H (PTEN mutation)Experimental Treatment4 Interventions
Patients with PTEN mutation receive copanlisib IV over 1 hour on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group VI: Subprotocol Z1G (PTEN loss)Experimental Treatment4 Interventions
Patients with PTEN loss receive copanlisib IV over 1 hour on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group VII: Subprotocol Z1F (PIK3CA mutation)Experimental Treatment7 Interventions
Patients receive copanlisib IV over 1 hour on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo tumor biopsies at screening and end of treatment as well as CT or MRI at baseline and repeated every 2 cycles for the first 26 cycles then every 3 cycles thereafter until progressive disease or start of another MATCH treatment step.
Group VIII: Subprotocol Z1E (NTRK1, NTRK2 or NTRK3 gene fusion)Experimental Treatment4 Interventions
Patients with NTRK1, NTRK2, or NTRK3 gene fusion receive larotrectinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group IX: Subprotocol Z1D (Loss of MLH1 or MSH2 by IHC)Experimental Treatment3 Interventions
Patients with mismatch repair deficiency (loss of MLH1 or MSH2 by IHC) receive nivolumab IV over 30 minutes on days 1 and 15 for 4 cycles and then on day 1 every 28 days. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group X: Subprotocol Z1C (CDK4 or CDK6 amplification and Rb protein)Experimental Treatment3 Interventions
Patients with CDK4 or CDK6 amplification and tumor Rb protein receive palbociclib PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group XI: Subprotocol Z1B (CCND1, 2, or 3 amplification with Rb by IHC)Experimental Treatment3 Interventions
Patients with CCND1, 2, or 3 amplification that have tumor Rb expression by IHC receive palbociclib PO QD for 21 days. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group XII: Subprotocol Z1A (NRAS mutation in codon 12, 13, or 61)Experimental Treatment3 Interventions
Patients with NRAS mutation in codon 12, 13, or 61 receive binimetinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group XIII: Subprotocol Y (Akt mutation)Experimental Treatment3 Interventions
Patients with Akt mutation receive capivasertib PO BID on days 1-4, 8-11, 15-18, and 22-25. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group XIV: Subprotocol X (DDR2 S768R, I638F, or L239R mutation)Experimental Treatment3 Interventions
Patients with DDR2 S768R, I638F, or L239R mutation receive dasatinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group XV: Subprotocol W (FGFR pathway aberrations)Experimental Treatment3 Interventions
Patients with FGFR1-3 mutation or translocation receive FGFR Inhibitor AZD4547 PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group XVI: Subprotocol V (cKIT exon 9, 11, 13, or 14 mutation)Experimental Treatment3 Interventions
Patients with cKIT exon 9, 11, 13, or 14 mutation receive sunitinib malate PO QD for 4 weeks. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
Group XVII: Subprotocol U (NF2 inactivating mutation)Experimental Treatment4 Interventions
Patients with NF2 inactivating mutation receive defactinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group XVIII: Subprotocol T (SMO or PTCH1 mutation)Experimental Treatment3 Interventions
Patients with SMO or PTCH1 mutation receive vismodegib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group XIX: Subprotocol S2 (GNAQ or GNA11 mutation)Experimental Treatment3 Interventions
Patients with GNAQ or GNA11 mutation receive trametinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group XX: Subprotocol S1 (NF1 mutation)Experimental Treatment3 Interventions
Patients with NF1 mutation receive trametinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group XXI: Subprotocol R (BRAF fusion or BRAF non-V600 mutation)Experimental Treatment3 Interventions
Patients with BRAF fusion or BRAF non-V600 mutation receive trametinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group XXII: Subprotocol Q (HER2 amplification)Experimental Treatment4 Interventions
Patients with HER2 amplification receive trastuzumab emtansine intravenously (IV) over 30-90 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Group XXIII: Subprotocol P (PTEN loss)Experimental Treatment3 Interventions
Patients with PTEN loss receive PI3K-beta inhibitor GSK2636771 PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group XXIV: Subprotocol N (PTEN mutation or deletion and PTEN expression)Experimental Treatment3 Interventions
Patients with PTEN mutation or deletion and PTEN expression receive PI3K-beta inhibitor GSK2636771 PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group XXV: Subprotocol M (TSC1 or TSC2 mutation)Experimental Treatment3 Interventions
Patients with TSC1 or TSC2 mutation receive sapanisertib PO daily on days 1-28. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Group XXVI: Subprotocol L (mTOR mutation)Experimental Treatment3 Interventions
Patients with mTOR mutation receive sapanisertib PO daily on days 1-28. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Group XXVII: Subprotocol K2 (FGFR mutation or fusion)Experimental Treatment3 Interventions
Patients with FGFR mutation or fusion receive erdafitinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group XXVIII: Subprotocol K1 (FGFR amplification)Experimental Treatment3 Interventions
Patients with FGFR amplification receive erdafitinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group XXIX: Subprotocol J (HER2 amplification >= 7 copy numbers)Experimental Treatment9 Interventions
Patients receive pertuzumab IV over 30-60 minutes and trastuzumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo radiologic evaluation throughout the trial, ECHO at screening and end of treatment, and biopsy and collection of blood samples on trial and at end of treatment.
Group XXX: Subprotocol I (PIK3CA mutation)Experimental Treatment3 Interventions
Patients with PIK3CA mutation without RAS mutation or PTEN loss receive taselisib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group XXXI: Subprotocol H (BRAF V600E/R/K/D mutation)Experimental Treatment5 Interventions
Patients with BRAF V600E/R/K/D mutation receive dabrafenib PO BID and trametinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group XXXII: Subprotocol G (ROS1 translocation or inversion)Experimental Treatment3 Interventions
Patients with ROS1 translocation or inversion receive crizotinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group XXXIII: Subprotocol F (ALK translocation)Experimental Treatment3 Interventions
Patients with ALK translocation receive crizotinib PO twice daily (BID) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group XXXIV: Subprotocol E (EGFR T790M or rare activating mutation)Experimental Treatment3 Interventions
Patients with EGFR T790M or rare activating mutation receive osimertinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group XXXV: Subprotocol C2 (MET exon 14 deletion/mutation)Experimental Treatment3 Interventions
Patients with MET exon 14 deletion or other mutations that disrupt exon 14 receive crizotinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group XXXVI: Subprotocol C1 (MET amplification)Experimental Treatment3 Interventions
Patients with MET amplification receive crizotinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group XXXVII: Subprotocol B (HER2 activating mutation)Experimental Treatment4 Interventions
Patients with HER2 activating mutation receive afatinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group XXXVIII: Subprotocol A (EGFR activating mutation)Experimental Treatment4 Interventions
Patients with EGFR activating mutation receive afatinib orally (PO) once daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 1
~1540
Echocardiography
2013
Completed Phase 4
~11670
Pertuzumab
2014
Completed Phase 3
~7500
Ipatasertib
2019
Completed Phase 3
~2060
Osimertinib
2017
Completed Phase 4
~1010
Dasatinib
2012
Completed Phase 2
~2200
Copanlisib
2016
Completed Phase 2
~120
Defactinib
2013
Completed Phase 1
~60
Adavosertib
2015
Completed Phase 2
~520
Afatinib
2013
Completed Phase 4
~2290
Afatinib Dimaleate
2015
Completed Phase 1
~60
Binimetinib
2018
Completed Phase 3
~990
Biopsy
2014
Completed Phase 4
~1180
Relatlimab
2018
Completed Phase 2
~1100
Sapanisertib
2016
Completed Phase 2
~760
Sunitinib Malate
2008
Completed Phase 3
~3070
Taselisib
2014
Completed Phase 2
~2230
Trastuzumab Emtansine
2016
Completed Phase 3
~5380
Capivasertib
2021
Completed Phase 1
~130
Dabrafenib
2011
Completed Phase 3
~4120
FGFR Inhibitor AZD4547
2014
Completed Phase 3
~1960
Dabrafenib Mesylate
2014
Completed Phase 2
~10
Erdafitinib
2017
Completed Phase 1
~110
Magnetic Resonance Imaging
2017
Completed Phase 3
~1250
Nivolumab
2014
Completed Phase 3
~4120
Computed Tomography
2017
Completed Phase 2
~2890
Trametinib
2014
Completed Phase 2
~1600
Palbociclib
2017
Completed Phase 3
~3720
Crizotinib
2021
Completed Phase 3
~2120
Trastuzumab
2014
Completed Phase 4
~8090
Vismodegib
2015
Completed Phase 4
~1880
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,486 Previous Clinical Trials
41,258,419 Total Patients Enrolled
Keith T FlahertyPrincipal InvestigatorECOG-ACRIN Cancer Research Group
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have started having periods at some point.You have had no signs of any other type of cancer for at least 5 years.You have been treated for basal cell or squamous cell skin cancer and it's under control.You have not had your uterus or ovaries removed, or have not had a natural menopause for at least 24 months (meaning you have had your period at any time in the past 24 months).Requirements for the initial biopsy used to determine if you are eligible for the clinical trial.You must use effective birth control or avoid sex before and during the study, and for 4 months after the study ends. If you or your partner become pregnant during the study, tell your doctor right away.You have a history of a specific type of blood cell disorder called lymphoproliferative disorder.You have had cancer that was actively growing.You have had cancer, except for basal cell carcinoma and squamous cell carcinoma, within the last 5 years.You have heart problems that can lead to abnormal heart rhythms, or you are taking medications that can affect your heart's rhythm.You have been diagnosed with a solid tumor, lymphoma, or multiple myeloma and need treatment for it.You need to provide a sample of your tumor tissue to confirm a specific genetic variation using a special test.You should be able to do most of your daily activities and have a life expectancy of at least 3 months.People with HIV may be allowed to participate if they meet certain requirements.You have already tried standard treatments for your condition and they did not work, or there are no other approved treatments available that can help you.Patients must have specific blood and body chemistry test results within a certain range.You need to have had a heart test within 8 weeks before joining the study, and your heart needs to meet specific health standards.
Research Study Groups:
This trial has the following groups:- Group 1: Subprotocol C2 (MET exon 14 deletion/mutation)
- Group 2: Subprotocol V (cKIT exon 9, 11, 13, or 14 mutation)
- Group 3: Subprotocol Z1A (NRAS mutation in codon 12, 13, or 61)
- Group 4: Subprotocol Z1M (LAG-3 expression >= 1%)
- Group 5: Subprotocol I (PIK3CA mutation)
- Group 6: Subprotocol A (EGFR activating mutation)
- Group 7: Subprotocol C1 (MET amplification)
- Group 8: Subprotocol B (HER2 activating mutation)
- Group 9: Subprotocol E (EGFR T790M or rare activating mutation)
- Group 10: Subprotocol K1 (FGFR amplification)
- Group 11: Subprotocol T (SMO or PTCH1 mutation)
- Group 12: Subprotocol F (ALK translocation)
- Group 13: Subprotocol P (PTEN loss)
- Group 14: Subprotocol H (BRAF V600E/R/K/D mutation)
- Group 15: Subprotocol L (mTOR mutation)
- Group 16: Subprotocol M (TSC1 or TSC2 mutation)
- Group 17: Subprotocol W (FGFR pathway aberrations)
- Group 18: Subprotocol G (ROS1 translocation or inversion)
- Group 19: Subprotocol J (HER2 amplification >= 7 copy numbers)
- Group 20: Subprotocol R (BRAF fusion or BRAF non-V600 mutation)
- Group 21: Subprotocol Z1F (PIK3CA mutation)
- Group 22: Subprotocol Q (HER2 amplification)
- Group 23: Subprotocol K2 (FGFR mutation or fusion)
- Group 24: Subprotocol Z1C (CDK4 or CDK6 amplification and Rb protein)
- Group 25: Subprotocol Z1K (AKT mutation)
- Group 26: Subprotocol U (NF2 inactivating mutation)
- Group 27: Subprotocol N (PTEN mutation or deletion and PTEN expression)
- Group 28: Subprotocol Z1D (Loss of MLH1 or MSH2 by IHC)
- Group 29: Subprotocol S1 (NF1 mutation)
- Group 30: Subprotocol Y (Akt mutation)
- Group 31: Subprotocol Z1E (NTRK1, NTRK2 or NTRK3 gene fusion)
- Group 32: Subprotocol S2 (GNAQ or GNA11 mutation)
- Group 33: Subprotocol X (DDR2 S768R, I638F, or L239R mutation)
- Group 34: Subprotocol Z1B (CCND1, 2, or 3 amplification with Rb by IHC)
- Group 35: Subprotocol Z1G (PTEN loss)
- Group 36: Subprotocol Z1H (PTEN mutation)
- Group 37: Subprotocol Z1L (BRAF fusion, aberration or non-V600 mutation)
- Group 38: Subprotocol Z1I (BRCA1 or BRCA2 gene mutation)
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.
Head and Neck Cancers Patient Testimony for trial: Trial Name: NCT02465060 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What prior investigations have included Subprotocol R considerations of BRAF union or non-V600 mutation?
"Presently, 1594 clinical trials are underway to evaluate Subprotocol R (BRAF fusion or BRAF non-V600 mutation), 237 of those being in the last phase. Most studies for this therapy take place in Seattle, Washington but there exist 890 other sites running these experiments."
Answered by AI
What is the intake capacity for this clinical research?
"To fulfill the requirements of this trial, 6452 eligible participants must enroll. These patients can join from various medical facilities such as Saint Jude Medical Center in Fullerton, Colorado and Providence Saint Joseph Medical Center/Disney Family Cancer Center situated in Burbank, Idaho."
Answered by AI
Are there any vacancies for individuals interested in participating in this research?
"Affirmative. According to the data on clinicaltrials.gov, this medical trial is currently recruiting patients and has been since August 12th 2015. The last update was made on November 30th 2022, with a total of 6452 participants needed from across 100 locations."
Answered by AI
How many healthcare establishments are administering this experiment?
"This research is recruiting patients from Saint Jude Medical Center in Fullerton, Colorado, Providence Saint Joseph Medical Center/Disney Family Cancer Center in Burbank, Idaho and Southwest Oncology PC in Durango, Connecticutt Oncoloon, Colorado, Providence Saint Joseph Medical Center/Disney Family Cancer Center in Burbank, Idaho and Southwest Oncology PC in Durango, Connecticut as well as other 100 sites."
Answered by AI
What medical conditions are typically treated through Subprotocol R (BRAF fusion or BRAF non-V600 mutation)?
"Subprotocol R (BRAF fusion or BRAF non-V600 mutation) is primarily used to address renal failure but can also be applied for the management of metastatic basal cell carcinoma, inoperable melanoma, and squamous cell carcinomas."
Answered by AI
Is Subprotocol R (BRAF fusion or BRAF non-V600 mutation) sanctioned by the FDA?
"Subprotocol R of this trial (BRAF fusion or BRAF non-V600 mutation) was assessed at a score 2 on the safety scale, as there is clinical data confirming its safety but no evidence to back up efficacy yet."
Answered by AI
Who else is applying?
What state do they live in?
Connecticut
Virginia
Texas
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
3+
What site did they apply to?
NYP/Weill Cornell Medical Center
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
MD Anderson League City
Why did patients apply to this trial?
Well I had a cancerous tumor removed June 2022, and received 6 rounds of chemo between August and November, stage 3a. But in January the CT scan was clear and the genetic blood test was clear and so I was cancer free. However in May of this a prostate biopsy was done and have fairly advanced cancer that has likely spread outside of the prostate. I have appointments with oncology and urology in the next couple of weeks to hopefully begin to get some clarification on what treatment they want to recommend.
PatientReceived 1 prior treatment
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