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Clinical Trial Summary

This phase II MATCH screening and multi-sub-trial studies how well treatment that is directed by genetic testing works in patients with solid tumors, lymphomas, or multiple myelomas that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and does not respond to treatment (refractory). Patients must have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors, lymphomas, or multiple myeloma.


Clinical Trial Description

PRIMARY OBJECTIVE: I. To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas/multiple myeloma. SECONDARY OBJECTIVES: I. To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas/multiple myeloma. II. To evaluate time until death or disease progression. III. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, ribonucleic acid (RNA), protein and imaging-based assessment platforms. IV. To assess whether radiomic phenotypes obtained from pre-treatment imaging and changes from pre- through post-therapy imaging can predict objective response and progression free survival and to evaluate the association between pre-treatment radiomic phenotypes and targeted gene mutation patterns of tumor biopsy specimens. OUTLINE: STEP 0 (Screening): Patients undergo biopsy along with molecular characterization of the biopsy material for specific, pre-defined mutations, amplifications, or translocations of interest via tumor sequencing and immunohistochemistry. Consenting patients also undergo collection of blood samples for research purposes. STEPS 1, 3, 5, 7 (Treatment): Patients are assigned to 1 of 38 treatment subprotocols based on molecularly-defined subgroup. (See Arms Section) STEPS 2, 4, 6 (Screening): Patients experiencing disease progression on the prior Step treatment or who could not tolerate the assigned treatment undergo review of their previous biopsy results to determine if another treatment is available or undergo another biopsy. Patients may have a maximum of 2 screening biopsies and 2 treatments per biopsy. STEP 8 (Optional Research): Consenting patients undergo end-of-treatment biopsy and collection of blood samples for research purposes. Additionally, patients may undergo a computed tomography (CT) scan, magnetic resonance imaging, and/or radionuclide imaging throughout the trial. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 1 year. ;


Study Design


Related Conditions & MeSH terms

  • Advanced Lymphoma
  • Advanced Malignant Solid Neoplasm
  • Bladder Carcinoma
  • Breast Carcinoma
  • Breast Neoplasms
  • Carcinoma
  • Carcinoma, Hepatocellular
  • Carcinoma, Ovarian Epithelial
  • Carcinoma, Renal Cell
  • Cervical Carcinoma
  • Colon Carcinoma
  • Colonic Neoplasms
  • Colorectal Carcinoma
  • Colorectal Neoplasms
  • Endometrial Carcinoma
  • Endometrial Neoplasms
  • Esophageal Carcinoma
  • Esophageal Neoplasms
  • Gastric Carcinoma
  • Glioma
  • Head and Neck Carcinoma
  • Hematopoietic and Lymphoid Cell Neoplasm
  • Kidney Carcinoma
  • Kidney Neoplasms
  • Liver Carcinoma
  • Lung Carcinoma
  • Lung Neoplasms
  • Lymphoma
  • Malignant Uterine Neoplasm
  • Melanoma
  • Multiple Myeloma
  • Neoplasms
  • Neoplasms, Plasma Cell
  • Ovarian Carcinoma
  • Ovarian Neoplasms
  • Pancreatic Carcinoma
  • Pancreatic Neoplasms
  • Prostate Carcinoma
  • Prostatic Neoplasms
  • Rectal Carcinoma
  • Rectal Neoplasms
  • Recurrence
  • Recurrent Bladder Carcinoma
  • Recurrent Breast Carcinoma
  • Recurrent Cervical Carcinoma
  • Recurrent Colon Carcinoma
  • Recurrent Colorectal Carcinoma
  • Recurrent Esophageal Carcinoma
  • Recurrent Gastric Carcinoma
  • Recurrent Glioma
  • Recurrent Head and Neck Carcinoma
  • Recurrent Liver Carcinoma
  • Recurrent Lung Carcinoma
  • Recurrent Lymphoma
  • Recurrent Malignant Solid Neoplasm
  • Recurrent Melanoma
  • Recurrent Multiple Myeloma
  • Recurrent Ovarian Carcinoma
  • Recurrent Pancreatic Carcinoma
  • Recurrent Prostate Carcinoma
  • Recurrent Rectal Carcinoma
  • Recurrent Skin Carcinoma
  • Recurrent Thyroid Gland Carcinoma
  • Recurrent Uterine Corpus Cancer
  • Refractory Lymphoma
  • Refractory Malignant Solid Neoplasm
  • Refractory Multiple Myeloma
  • Skin Carcinoma
  • Skin Neoplasms
  • Stomach Neoplasms
  • Thyroid Diseases
  • Thyroid Gland Carcinoma
  • Thyroid Neoplasms
  • Urinary Bladder Neoplasms
  • Uterine Corpus Cancer
  • Uterine Neoplasms

NCT number NCT02465060
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Active, not recruiting
Phase Phase 2
Start date August 17, 2015
Completion date December 31, 2025

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