Clinical trials: CDKN2A Mutation
Advanced Solid Tumor, CDKN2A
Milademetan in Combination With Atezolizumab in Patients With Advanced Solid Tumors With CDKN2A Loss
This is an open-label, single-arm, Phase 1b/2 study designed to evaluate the safety, tolerability, and preliminary efficacy of milademetan in combination with atezolizumab in patients with advanced solid tumors with confirmed…
- Conditions
- Advanced Solid Tumor, CDKN2A, NSCLC, Urothelial Carcinoma Bladder
- Trial name
- NCT06090318
- Testing
- Milademetan, Atezolizumab
- Sponsor
- Rain Oncology Inc
Solid Tumors
A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5)
This is an open-label, multicenter Phase 2 study evaluating BMS-986504 in participants with advanced and/or metastatic solid tumors that have MTAP deletion.
- Trial name
- NCT07492680
- Testing
- BMS-986504, Daraxonrasib, Nivolumab + Relatlimab FDC
- Where
- 58 sites in United States, Belgium and 11 more
- Volunteers
- 260 people
- Sponsor
- Bristol-Myers Squibb
BRCA1 Mutation, POLD1 Gene Mutation
An Intervention to Increase Genetic Testing in Families Who May Share a Gene Mutation Related to Cancer Risk and An Intervention to Help Patients and Their Primary Care Providers Stay Up-to-date About Uncertain Genetic Test Results
The purpose of this study is to examine the impact of new cancer genetic counseling models that aim to increase patient engagement with the genetics team.
- Conditions
- BRCA1 Mutation, POLD1 Gene Mutation, CDKN2A Mutation, BRCA2 Mutation
- Trial name
- NCT05420064
- Testing
- Intervention Arm At-risk Relative/ARR Contacts, MyGene Portal, Standard of Care
- Where
- 8 sites in United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Memorial Sloan Kettering Cancer Center
Small Cell Lung Cancer
Phase II, Single-arm Study of AZD1775 Monotherapy in Relapsed Small Cell Lung Cancer Patients With MYC Family Amplification or CDKN2A Mutation Combined With TP53 Mutation
AZD1775 (previously known as MK-1775 in earlier studies) is an inhibitor of Wee1, a protein tyrosine kinase. Wee1 phosphorylates and inhibits cyclin-dependent kinases 1 (CDK1) and 2 (CDK2), and is involved in regulation of the…
- Trial name
- NCT02688907
- Testing
- AZD1775
- Where
- South Korea
- Volunteers
- 7 people
- Sponsor
- Samsung Medical Center
Head and Neck Squamous Cell Carcinoma
A Phase II Study of Anti-EGFR Antibody-drug Conjugate (ADC) Combine With CDK4/6 Inhibitors Posterior Line in the Treatment of Recurrent/Metastatic CDKN2A Gene Variant Head and Neck Squamous Cell Carcinoma
A Single-arm, Phase II Study of MRG003 combined with Dalpicicilip posterior line in the treatment of recurrent/metastatic CDKN2A gene variant head and neck squamous cell carcinoman (HNSCC).
- Trial name
- NCT06509997
- Testing
- MRG003 combined with Dalpicicilip
- Volunteers
- 30 people
- Sponsor
- Lei Liu
Advanced Cancers
Phase II Study of Ilorasertib (ABT348) in Patients With CDKN2A Deficient Solid Tumors
The goal of this clinical research study is to learn if ilorasertib (ABT-348) can help to control CDKN2A-deficient cancer. CDKN2A deficiency is a type of mutation (a genetic change). The safety of this drug will also be studied.
- Trial name
- NCT02478320
- Testing
- Ilorasertib
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- M.D. Anderson Cancer Center
Advanced Solid Tumors
A Study to Assess Safety, Tolerability and Drug Levels of Navlimetostat (BMS-986504) in Participants With Advanced Solid Tumors
The purpose of this study is to evaluate the safety, tolerability and drug levels of Navlimetostat (BMS-986504) in participants with advanced solid tumors.
- Trial name
- NCT07077434
- Testing
- BMS-986504
- Where
- 12 sites in China, Japan
- Volunteers
- 32 people
- Sponsor
- Bristol-Myers Squibb
GBM, Glioblastoma
Abemaciclib w/Bevacizumab in Recurrent GBM Pts w/Loss of CDKN2A/B or Gain or Amplification of CDK4/6
Describe the safety and adverse events associated with Abemaciclib 150 mg orally twice daily when administered with Bevacizumab 10 mg/kg intravenously every 2 weeks to recurrent GBM patients with specific tumor molecular…
- Conditions
- GBM, Glioblastoma, Brain Tumor, Brain Tumor, Recurrent
- Trial name
- SCCC-06319 (NCT04074785)
- Testing
- Abemaciclib, Bevacizumab
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of Texas Southwestern Medical Center
Head and Neck Cancer, Advanced Cancer
Evaluation of ABEMACICLIB Monotherapy in Patients With Locally Advanced/Metastatic Head and Neck Cancer After Failure of Platinum and Cetuximab or Anti-EGFR-based Therapy and Harboring an Homozygous Deletion of CDKN2A, and/or an Amplification of CCND1 and/or of CDK6
This trial is an open-label, single arm, Phase II study using an A'Hern single stage design. The molecular prescreening step will allow to defined HPV tumor status as well as molecular status CDKN2A, CCND1 and CDK6.
- Conditions
- Head and Neck Cancer, Advanced Cancer, Metastatic Cancer
- Trial name
- ABORL (NCT03356223)
- Testing
- Abemaciclib
- Where
- 3 sites in France
- Volunteers
- 25 people
- Sponsor
- Centre Leon Berard
CDKN2A-p16 Positive, HPV Positive Oropharyngeal Squamous Cell Carcinoma
Alpelisib in Treating Participants With Transorally Resectable HPV-Associated Stage I-IVA Oropharyngeal Cancer
This phase II trial studies how well alpelisib works in treating participants with human papillomavirus(HPV)-associated stage I-IVA head and neck cancer that can be removed by surgery.
- Conditions
- CDKN2A-p16 Positive, HPV Positive Oropharyngeal Squamous Cell Carcinoma, Stage I Oropharyngeal Squamous Cell Carcinoma AJCC V7, Stage II Oropharyngeal Squamous Cell Carcinoma AJCC V7
- Trial name
- NCT03601507
- Testing
- Alpelisib, Laboratory Biomarker Analysis, Pharmacodynamic Study
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- University of Arizona
Solid Tumors
Phase Ib Study of Alpelisib With Cisplatin in Patients With HPV+ Solid Tumor Malignancies
This phase Ib trial studies the best dose and side effects of alpelisib and cisplatin in treating patients with human papillomavirus (HPV) positive solid tumor malignancies.
- Trial name
- NCT02620839
- Testing
- Alpelisib, Cisplatin
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Pamela Munster
Advanced Solid Tumors, Lymphoma
Study of AG-270 in Participants With Advanced Solid Tumors or Lymphoma With MTAP Loss
This study will evaluate the safety, pharmacokinetics, pharmacodynamics, and clinical activity of AG-270 in participants with advanced solid tumors or lymphoma with homozygous MTAP deletion.
- Trial name
- NCT03435250
- Testing
- AG-270, docetaxel, nab-paclitaxel
- Where
- 8 sites in United States, France and 1 more
- Volunteers
- 123 people
- Sponsor
- Institut de Recherches Internationales Servier
Pancreas Cancer, Peutz-Jeghers Syndrome (PJS)
The Cancer of the Pancreas Screening-5 CAPS5)Study
Johns Hopkins clinical research office quality assurance group will monitor and audit this study at Johns Hopkins. The Sub Investigator at each site will be responsible for internal monitoring at their site.
- Conditions
- Pancreas Cancer, Peutz-Jeghers Syndrome (PJS), Gene Mutation, Germline Mutation Carrier
- Trial name
- CAPS5 (NCT02000089)
- Testing
- Secretin, MRI, Tumor marker gene test with CA19-9
- Where
- 9 sites in United States
- Volunteers
- 9,000 people
- Sponsor
- Johns Hopkins University
Melanoma (Skin Cancer)
A Comparative Usability Study of Two Total Body Skin Imaging Systems
This study aims to generate evidence on patient and dermatologist perspectives regarding two total body photography systems. Patient and clinician preferences represent key factors in healthcare decision-making.
- Trial name
- NCT07740642
- Testing
- Deviskan, Vectra WB360, Standard-of-care clinical examinations
- Where
- Switzerland
- Volunteers
- 60 people
- Sponsor
- University Hospital, Basel, Switzerland
Pancreatic Cancer
Mutation of K-RAS, CDKN2A, SMAD4 and TP53 in Pancreatic Cancer: Role of Liquid Biopsy in Preoperative Diagnosis
Pancreatic cancers represent a challenge for the multidisciplinal team. A patient-tailored treatment plan requires an accurate preoperative staging.
- Trial name
- NCT03524677
- Testing
- Liquid Biopsy
- Where
- 3 sites in Ireland, Italy
- Volunteers
- 50 people
- Sponsor
- University of Roma La Sapienza
HPV-unrelated Head and Neck Squamous Cell Carcinoma
Palbociclib and Cetuximab Versus Cetuximab Monotherapy for Patients With CDKN2A-altered, HPV-unrelated Head and Neck Squamous Cell Carcinoma Who Experienced Disease Progression on a PD-1/L1 Inhibitor
This multicenter, open-label, randomized phase 3 trial will determine if palbociclib and cetuximab (Arm 1) improves overall survival (OS) in comparison to cetuximab monotherapy (Arm 2) in patients with CDKN2A-altered…
- Trial name
- NCT04966481
- Testing
- Palbociclib, Cetuximab
- Where
- 5 sites in United States
- Volunteers
- 81 people
- Sponsor
- Washington University School of Medicine
Metastatic Non-small Cell Lung Cancer With MTAP Deletion
A Study to Compare the Combination of Navlimetostat (BMS-986504) With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion
The purpose of this study is to compare the clinical benefit of the combination of Navlimetostat (BMS-986504) (a selective MTA-cooperative inhibitor of PRMT5) plus pembrolizumab and chemotherapy versus placebo plus pembrolizumab…
- Trial name
- MountainTAP-29 (NCT07063745)
- Testing
- BMS-986504, Pembrolizumab, Cisplatin
- Where
- 321 sites in United States, Argentina and 32 more
- Volunteers
- 590 people
- Sponsor
- Bristol-Myers Squibb
T-cell Lymphoma, Aggressive B-cell Lymphoma
p53/p16-Independent Epigenetic Therapy With Oral Decitabine/Tetrahydrouridine for Refractory/Relapsed Lymphoid Malignancies
The purpose of this study is to evaluate how well the study drug works and safety of oral decitabine in patients with refractory or relapsed lymphoid malignancies.
- Conditions
- T-cell Lymphoma, Aggressive B-cell Lymphoma, Non-Hodgkin's Lymphomas, Indolent B-cell Lymphoma
- Trial name
- NCT02846935
- Testing
- Decitabine, Tetrahydrouridine
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Yogen Saunthararajah
Metastatic Malignant Neoplasm, Solid Neoplasm
Ilorasertib in Treating Patients With CDKN2A-deficient Advanced or Metastatic Solid Cancers That Cannot Be Removed by Surgery
This pilot phase I trial studies how well ilorasertib works in treating patients with cyclin-dependent kinase inhibitor 2A (CDKN2A)-deficient solid cancers that have spread to other places in the body and usually cannot be cured…
- Conditions
- Metastatic Malignant Neoplasm, Solid Neoplasm, Unresectable Malignant Neoplasm
- Trial name
- NCT02540876
- Testing
- Ilorasertib, Laboratory Biomarker Analysis
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- University of Chicago
Solid Tumor
Study of IDE397 in Participants With Solid Tumors Harboring MTAP Deletion
This is a Phase 1, open-label, multicenter, dose escalation and expansion study of the safety, PK, PD, and preliminary anti-tumor activity of IDE397 as a single agent and in combination with sacituzumab govitecan (SG), in adult…
- Trial name
- NCT04794699
- Testing
- IDE397, Sacituzumab govitecan
- Where
- 37 sites in United States, Australia and 5 more
- Volunteers
- 169 people
- Sponsor
- IDEAYA Biosciences