Subprotocol R (BRAF fusion or BRAF non-V600 mutation) for Lymphoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Lymphoma+76 More
Trastuzumab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

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
  • Lymphoma
  • Multiple Myeloma
  • Carcinoma
  • Esophageal Carcinoma
  • Recurrent Liver Carcinoma
  • Oxytocics
  • Melanoma
  • Urinary Bladder
  • Head and Neck Carcinoma
  • Lung, Carcinoma
  • Ovarian Carcinoma
  • Recurrent Bladder Carcinoma
  • Recurrent Colon Carcinoma
  • Recurrent Esophageal Carcinoma
  • Recurrent Gastric Carcinoma
  • Glioma
  • Recurrent Ovarian Carcinoma
  • Pancreatic carcinoma
  • Rectal Carcinoma
  • Renal Carcinoma
  • Prostate Cancer
  • Colorectal Carcinoma
  • Recurrent Prostate Carcinoma
  • Malignant Neoplasms
  • Refractory Lymphomas
  • Advance Directives
  • Breast Carcinoma
  • Colon Carcinoma
  • Gastric Carcinoma
  • Recurrent Malignant Solid Neoplasm
  • Recurrent Melanoma
  • Refractory Plasma Cell Myeloma
  • Uterine Cancer
  • Breast
  • Endometrial Carcinoma
  • Cervical Carcinoma
  • Recurrent Cervical Carcinoma
  • Liver

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Up to 3 years

Month 6
Progression free survival
Year 3
Overall survival
Up to 3 years
Objective response rate

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

38 Treatment Groups

Subprotocol R (BRAF fusion or BRAF non-V600 mutation)
1 of 38
Subprotocol B (HER2 activating mutation)
1 of 38
Subprotocol A (EGFR activating mutation)
1 of 38
Subprotocol C1 (MET amplification)
1 of 38
Subprotocol Z1F (PIK3CA mutation)
1 of 38
Subprotocol Z1K (AKT mutation)
1 of 38
Subprotocol P (PTEN loss)
1 of 38
Subprotocol Z1M (LAG-3 expression >= 1%)
1 of 38
Subprotocol C2 (MET exon 14 deletion/mutation)
1 of 38
Subprotocol E (EGFR T790M or rare activating mutation)
1 of 38
Subprotocol Z1C (CDK4 or CDK6 amplification and Rb protein)
1 of 38
Subprotocol K2 (FGFR mutation or fusion)
1 of 38
Subprotocol G (ROS1 translocation or inversion)
1 of 38
Subprotocol F (ALK translocation)
1 of 38
Subprotocol L (mTOR mutation)
1 of 38
Subprotocol H (BRAF V600E/R/K/D mutation)
1 of 38
Subprotocol V (cKIT exon 9, 11, 13, or 14 mutation)
1 of 38
Subprotocol I (PIK3CA mutation)
1 of 38
Subprotocol M (TSC1 or TSC2 mutation)
1 of 38
Subprotocol J (HER2 amplification >= 7 copy numbers)
1 of 38
Subprotocol K1 (FGFR amplification)
1 of 38
Subprotocol Q (HER2 amplification)
1 of 38
Subprotocol T (SMO or PTCH1 mutation)
1 of 38
Subprotocol W (FGFR pathway aberrations)
1 of 38
Subprotocol Z1A (NRAS mutation in codon 12, 13, or 61)
1 of 38
Subprotocol U (NF2 inactivating mutation)
1 of 38
Subprotocol N (PTEN mutation or deletion and PTEN expression)
1 of 38
Subprotocol Z1D (Loss of MLH1 or MSH2 by IHC)
1 of 38
Subprotocol S1 (NF1 mutation)
1 of 38
Subprotocol Y (Akt mutation)
1 of 38
Subprotocol Z1E (NTRK1, NTRK2 or NTRK3 gene fusion)
1 of 38
Subprotocol S2 (GNAQ or GNA11 mutation)
1 of 38
Subprotocol X (DDR2 S768R, I638F, or L239R mutation)
1 of 38
Subprotocol Z1B (CCND1, 2, or 3 amplification with Rb by IHC)
1 of 38
Subprotocol Z1G (PTEN loss)
1 of 38
Subprotocol Z1H (PTEN mutation)
1 of 38
Subprotocol Z1L (BRAF fusion, aberration or non-V600 mutation)
1 of 38
Subprotocol Z1I (BRCA1 or BRCA2 gene mutation)
1 of 38
Experimental Treatment

6452 Total Participants · 38 Treatment Groups

Primary Treatment: Subprotocol R (BRAF fusion or BRAF non-V600 mutation) · No Placebo Group · Phase 2

Subprotocol R (BRAF fusion or BRAF non-V600 mutation)Experimental Group · 3 Interventions: Cytology Specimen Collection Procedure, Trametinib, Laboratory Biomarker Analysis · Intervention Types: Other, Drug, Other
Subprotocol B (HER2 activating mutation)Experimental Group · 4 Interventions: Cytology Specimen Collection Procedure, Afatinib, Afatinib Dimaleate, Laboratory Biomarker Analysis · Intervention Types: Other, Drug, Drug, Other
Subprotocol A (EGFR activating mutation)Experimental Group · 4 Interventions: Cytology Specimen Collection Procedure, Afatinib, Afatinib Dimaleate, Laboratory Biomarker Analysis · Intervention Types: Other, Drug, Drug, Other
Subprotocol C1 (MET amplification)Experimental Group · 3 Interventions: Cytology Specimen Collection Procedure, Crizotinib, Laboratory Biomarker Analysis · Intervention Types: Other, Drug, Other
Subprotocol Z1F (PIK3CA mutation)Experimental Group · 7 Interventions: Cytology Specimen Collection Procedure, Biopsy, Computed Tomography, Copanlisib, Copanlisib Hydrochloride, Magnetic Resonance Imaging, Laboratory Biomarker Analysis · Intervention Types: Other, Procedure, Procedure, Drug, Drug, Procedure, Other
Subprotocol Z1K (AKT mutation)Experimental Group · 3 Interventions: Cytology Specimen Collection Procedure, Ipatasertib, Laboratory Biomarker Analysis · Intervention Types: Other, Drug, Other
Subprotocol P (PTEN loss)Experimental Group · 3 Interventions: Cytology Specimen Collection Procedure, Laboratory Biomarker Analysis, PI3K-beta Inhibitor GSK2636771 · Intervention Types: Other, Other, Drug
Subprotocol Z1M (LAG-3 expression >= 1%)Experimental Group · 4 Interventions: Cytology Specimen Collection Procedure, Nivolumab, Laboratory Biomarker Analysis, Relatlimab · Intervention Types: Other, Biological, Other, Biological
Subprotocol C2 (MET exon 14 deletion/mutation)Experimental Group · 3 Interventions: Cytology Specimen Collection Procedure, Crizotinib, Laboratory Biomarker Analysis · Intervention Types: Other, Drug, Other
Subprotocol E (EGFR T790M or rare activating mutation)Experimental Group · 3 Interventions: Cytology Specimen Collection Procedure, Laboratory Biomarker Analysis, Osimertinib · Intervention Types: Other, Other, Drug
Subprotocol Z1C (CDK4 or CDK6 amplification and Rb protein)Experimental Group · 3 Interventions: Cytology Specimen Collection Procedure, Palbociclib, Laboratory Biomarker Analysis · Intervention Types: Other, Drug, Other
Subprotocol K2 (FGFR mutation or fusion)Experimental Group · 3 Interventions: Cytology Specimen Collection Procedure, Erdafitinib, Laboratory Biomarker Analysis · Intervention Types: Other, Drug, Other
Subprotocol G (ROS1 translocation or inversion)Experimental Group · 3 Interventions: Cytology Specimen Collection Procedure, Crizotinib, Laboratory Biomarker Analysis · Intervention Types: Other, Drug, Other
Subprotocol F (ALK translocation)Experimental Group · 3 Interventions: Cytology Specimen Collection Procedure, Crizotinib, Laboratory Biomarker Analysis · Intervention Types: Other, Drug, Other
Subprotocol L (mTOR mutation)Experimental Group · 3 Interventions: Cytology Specimen Collection Procedure, Laboratory Biomarker Analysis, Sapanisertib · Intervention Types: Other, Other, Drug
Subprotocol H (BRAF V600E/R/K/D mutation)Experimental Group · 5 Interventions: Cytology Specimen Collection Procedure, Trametinib, Dabrafenib, Dabrafenib Mesylate, Laboratory Biomarker Analysis · Intervention Types: Other, Drug, Drug, Drug, Other
Subprotocol V (cKIT exon 9, 11, 13, or 14 mutation)Experimental Group · 3 Interventions: Cytology Specimen Collection Procedure, Sunitinib Malate, Laboratory Biomarker Analysis · Intervention Types: Other, Drug, Other
Subprotocol I (PIK3CA mutation)Experimental Group · 3 Interventions: Cytology Specimen Collection Procedure, Taselisib, Laboratory Biomarker Analysis · Intervention Types: Other, Drug, Other
Subprotocol M (TSC1 or TSC2 mutation)Experimental Group · 3 Interventions: Cytology Specimen Collection Procedure, Laboratory Biomarker Analysis, Sapanisertib · Intervention Types: Other, Other, Drug
Subprotocol J (HER2 amplification >= 7 copy numbers)Experimental Group · 5 Interventions: Trastuzumab, Cytology Specimen Collection Procedure, Pertuzumab, Laboratory Biomarker Analysis, Trastuzumab Emtansine · Intervention Types: Biological, Other, Biological, Other, Biological
Subprotocol K1 (FGFR amplification)Experimental Group · 3 Interventions: Cytology Specimen Collection Procedure, Erdafitinib, Laboratory Biomarker Analysis · Intervention Types: Other, Drug, Other
Subprotocol Q (HER2 amplification)Experimental Group · 4 Interventions: Trastuzumab, Cytology Specimen Collection Procedure, Laboratory Biomarker Analysis, Trastuzumab Emtansine · Intervention Types: Biological, Other, Other, Biological
Subprotocol T (SMO or PTCH1 mutation)Experimental Group · 3 Interventions: Cytology Specimen Collection Procedure, Laboratory Biomarker Analysis, Vismodegib · Intervention Types: Other, Other, Drug
Subprotocol W (FGFR pathway aberrations)Experimental Group · 3 Interventions: Cytology Specimen Collection Procedure, FGFR Inhibitor AZD4547, Laboratory Biomarker Analysis · Intervention Types: Other, Drug, Other
Subprotocol Z1A (NRAS mutation in codon 12, 13, or 61)Experimental Group · 3 Interventions: Cytology Specimen Collection Procedure, Binimetinib, Laboratory Biomarker Analysis · Intervention Types: Other, Drug, Other
Subprotocol U (NF2 inactivating mutation)Experimental Group · 4 Interventions: Cytology Specimen Collection Procedure, Defactinib Hydrochloride, Defactinib, Laboratory Biomarker Analysis · Intervention Types: Other, Drug, Drug, Other
Subprotocol N (PTEN mutation or deletion and PTEN expression)Experimental Group · 3 Interventions: Cytology Specimen Collection Procedure, Laboratory Biomarker Analysis, PI3K-beta Inhibitor GSK2636771 · Intervention Types: Other, Other, Drug
Subprotocol Z1D (Loss of MLH1 or MSH2 by IHC)Experimental Group · 3 Interventions: Cytology Specimen Collection Procedure, Nivolumab, Laboratory Biomarker Analysis · Intervention Types: Other, Biological, Other
Subprotocol S1 (NF1 mutation)Experimental Group · 3 Interventions: Cytology Specimen Collection Procedure, Trametinib, Laboratory Biomarker Analysis · Intervention Types: Other, Drug, Other
Subprotocol Y (Akt mutation)Experimental Group · 3 Interventions: Cytology Specimen Collection Procedure, Capivasertib, Laboratory Biomarker Analysis · Intervention Types: Other, Drug, Other
Subprotocol Z1E (NTRK1, NTRK2 or NTRK3 gene fusion)Experimental Group · 4 Interventions: Cytology Specimen Collection Procedure, Larotrectinib, Larotrectinib Sulfate, Laboratory Biomarker Analysis · Intervention Types: Other, Drug, Drug, Other
Subprotocol S2 (GNAQ or GNA11 mutation)Experimental Group · 3 Interventions: Cytology Specimen Collection Procedure, Trametinib, Laboratory Biomarker Analysis · Intervention Types: Other, Drug, Other
Subprotocol X (DDR2 S768R, I638F, or L239R mutation)Experimental Group · 3 Interventions: Cytology Specimen Collection Procedure, Dasatinib, Laboratory Biomarker Analysis · Intervention Types: Other, Drug, Other
Subprotocol Z1B (CCND1, 2, or 3 amplification with Rb by IHC)Experimental Group · 3 Interventions: Cytology Specimen Collection Procedure, Palbociclib, Laboratory Biomarker Analysis · Intervention Types: Other, Drug, Other
Subprotocol Z1G (PTEN loss)Experimental Group · 4 Interventions: Cytology Specimen Collection Procedure, Copanlisib, Copanlisib Hydrochloride, Laboratory Biomarker Analysis · Intervention Types: Other, Drug, Drug, Other
Subprotocol Z1H (PTEN mutation)Experimental Group · 4 Interventions: Cytology Specimen Collection Procedure, Copanlisib, Copanlisib Hydrochloride, Laboratory Biomarker Analysis · Intervention Types: Other, Drug, Drug, Other
Subprotocol Z1L (BRAF fusion, aberration or non-V600 mutation)Experimental Group · 3 Interventions: Cytology Specimen Collection Procedure, Laboratory Biomarker Analysis, Ulixertinib · Intervention Types: Other, Other, Drug
Subprotocol Z1I (BRCA1 or BRCA2 gene mutation)Experimental Group · 3 Interventions: Cytology Specimen Collection Procedure, Adavosertib, Laboratory Biomarker Analysis · Intervention Types: Other, Drug, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab
FDA approved
Binimetinib
FDA approved
Sunitinib
FDA approved
Taselisib
Not yet FDA approved
Palbociclib
FDA approved
Capivasertib
Not yet FDA approved
FGFR Inhibitor AZD4547
2014
Completed Phase 3
~1960
Ipatasertib
Not yet FDA approved
Pertuzumab
FDA approved
Biopsy
2014
Completed Phase 4
~1120
Afatinib
FDA approved
MK-1775
Not yet FDA approved
Computed Tomography
2017
Completed Phase 2
~3410
Trametinib
FDA approved
Afatinib
FDA approved
Copanlisib
FDA approved
Dabrafenib
FDA approved
Erdafitinib
FDA approved
Nivolumab
FDA approved
Tyrosine
FDA approved
Magnetic Resonance Imaging
2017
Completed Phase 2
~1100
Dasatinib
FDA approved
Methane
Not yet FDA approved
Defactinib
Not yet FDA approved
Trastuzumab emtansine
FDA approved
Relatlimab
Not yet FDA approved
Sapanisertib
Not yet FDA approved
Vismodegib
FDA approved
Osimertinib
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
12,990 Previous Clinical Trials
41,291,186 Total Patients Enrolled
1,337 Trials studying Lymphoma
374,177 Patients Enrolled for Lymphoma
Keith T FlahertyPrincipal InvestigatorECOG-ACRIN Cancer Research Group

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
will also be eligible Patients must have progressed following at least one line of standard systemic therapy and there must not be other approval/standard therapy available that has been shown to prolong overall survival (i.e
that has not responded to standard therapy Patients must have a disease that can be measured and that has not responded to standard therapy.
At some point, the person has achieved menarche.
has not had a hysterectomy, has not had bilateral oophorectomy, or has not been naturally postmenopausal for at least 24 consecutive months.
People who participate in this study cannot expect to get pregnant or father children using accepted and effective methods of contraception or by not having sex before entering the study, during the study, and for four months after finishing the study
You have had a basal cell or squamous cell skin cancer.
has about a five-year survival rate The currently available five-year survival rate for adequately treated stage I or II cancer from which the patient is currently in complete remission is about five years.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 25th, 2021

Last Reviewed: October 13th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References