Clinical Trials

Title   SWOG 1609 (DART)
Principal Investigator/ Physician   Sachin Pai, MD
Protocol┬áNo.   SWOG 1609
Open Date   05/01/2017
Gender   Both
Cancer Site   Solid Tumor
Status   Open
Sponsor   SWOG
Contact Email   MCI Clinical Trials
Summary  

Protocol: "DART: DUAL ANTI-CTLA-4 AND ANTI-PD-1 BLOCKADE IN RARE TUMORS”

Inclusion Criteria: Patients must have histologically confirmed rare cancer and/or cancer of unknown primary, that did not have a match to a molecularly-guided therapy on EAY131 "National Cancer Institute (NCI)-Molecular Analysis for Therapy Choice (MATCH)" protocol or who progressed on molecularly-matched therapy and have no further molecularly-matched treatment recommendations per EAY131, "NCI-MATCH", Patients that are determined to have a rare cancer with unknown primary site are eligible provided that there is histologic documentation of metastatic malignancy with no discernible primary site identified from histopathologic review, physical exam and associated cross-sectional imaging of the chest, abdomen, and pelvis, No other prior malignancy is allowed except for the following: Adequately managed stage I or II cancer from which the patient is currently in complete remission, any other cancer from which the patient has been disease free for five years, adequately managed stage I or II follicular thyroid or prostate cancer is also eligible, wherein patient is not required to be in complete remission, Patients with clinically controlled thyroiditis or pituitary disorders on stable replacement therapy are eligible.

Exclusion Criteria: Patients are not eligible if they have had or are planned for solid organ transplant; patients who have received allogeneic hematopoietic stem cell transplant are eligible if the transplant occurred at least 90 days prior to registration, patient has no prior acute graft versus host disease (GVHD), and within 48 hours of registration, patient demonstrates at least 90% engraftment, defined as: absolute neutrophil count (ANC) >= 500 mcl, measured over 3 consecutive days or 1 day with an ANC >= 1,000 mcl, or platelets >= 50,000 mcl measured, wherein the patient did not receive any platelet transfusions within 7 days prior to laboratory assessment, patients with autoimmune disease who are otherwise eligible under criterion 5.3 k must not have received steroid and immunosuppressive therapy within 28 days prior to registration; Patients must not have active autoimmune disease that has required systemic treatment in past 2 years; Patients must not have any uncontrolled intercurrent illness including (not limited to): symptomatic congestive heart failure (CHF) (New York Heart Association [NYHA] III/IV), unstable angina pectoris or coronary angioplasty, or stenting within 24 weeks prior to registration, unstable cardiac arrhythmia (ongoing cardiac dysrhythmias of NCI Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4 grade >= 2), known psychiatric illness that would limit study compliance, intra-cardiac defibrillators, known cardiac metastases, or abnormal cardiac valve morphology (>= grade 3)

 

Clinical Trial.Gov Link: https://clinicaltrials.gov/ct2/show/NCT02834013?term=SWOG+1609&rank=1

Email Newsletters

Connect With Us