Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD UCSF
Dates
study started
estimated completion
Principal Investigator
by Rana McKay, M.D. (ucsd)Jonathan Chou, M.D., Ph.D. (ucsf)
Photo of Rana McKay
Rana McKay
Photo of Jonathan Chou
Jonathan Chou

Description

Summary

This study will attempt to determine the efficacy of checkpoint inhibitor immunotherapy with nivolumab and ipilimumab combination therapy followed by nivolumab monotherapy in patients with metastatic prostate cancer harboring loss of CDK12 function.

Official Title

IMPACT: Immunotherapy in Patients With Metastatic Cancers and CDK12 Mutations

Details

This study investigates the efficacy of checkpoint inhibitor immunotherapy in patients with metastatic cancer with CDK12 mutations. The study includes two cohorts of patient groups: castration resistant metastatic prostate carcinoma and other solid tumor histologies. Both cohorts receive the same treatment with the combination of nivolumab and ipilimumab followed by nivolumab.

Keywords

Metastatic Castration Resistant Prostate Cancer Metastatic Cancer mCRPC Immunotherapy CDK12 Prostatic Neoplasms Neoplasm Metastasis Neoplasms Neoplasms, Second Primary Nivolumab Ipilimumab Metastatic CRPC Solid Tumors (non-prostate)

Eligibility

You can join if…

Open to people ages 18 years and up

  • Be ≥18 years of age as of date of signing informed consent.
  • Be willing and able to provide written informed consent for the study.
  • ECOG Performance Status of 0, 1 or 2 (Eastern Cooperative Oncology Group scoring system used to quantify general well-being and activities of daily life; scores range from 0 to 5 where 0 represents perfect health and 5 represents death.
  • Subjects must have a histologic or cytologic diagnosis of metastatic adenocarcinoma of the prostate without small cell histology OR another type of metastatic carcinoma.
  • All subjects, regardless of cancer type, must have a documented CDK12 aberration in tumor tissue.
  • Subjects with prostate cancer must have documented prostate cancer progression within six months prior to screening with PSA progression defined as a minimum of three rising PSA levels ≥ 1; 1 week between each assessment with a baseline PSA value at screening of ≥ 2 ng/mL.
  • Subjects with prostate cancer must have ongoing androgen deprivation with total serum testosterone < 50 ng/dL (or ≤ 0.50 ng/mL or 1.73 nmol/L)). If the subject is currently being treated with LHRH agonists (subjects who have not undergone an orchiectomy), this therapy must have been initiated at least 4 weeks prior to registration. This treatment must be continued throughout the study.
  • Subjects with non-prostate histologies must have RECIST 1.1-measurable cancer on computed tomography (CT) or magnetic resonance imaging (MRI) scans.
  • Subjects must have recovered to baseline or ≤ grade 1 toxicities related to any prior treatments unless AE(s) are clinically non-significant and/or stable.
  • Patients must be ≥ 2 weeks from most recent systemic therapy or most recent radiation therapy.
  • Women of childbearing potential must have a negative serum or urine pregnancy test within 28 days prior to registration.
  • Female and male subjects of reproductive potential must agree to use an adequate method of contraception starting with the first dose of study therapy through 5 months (for women) and 7 months (for men) after the last dose of study therapy.
  • Adequate organ and marrow function

You CAN'T join if...

  • Prior treatment with anti-PD-1/PD-L1 and anti-CTLA-4 is NOT allowed. Prior intravesical BCG therapy is allowed.
  • Treatment with any investigational agent or on an interventional clinical trial within 28 days prior to registration.
  • Prior or concurrent malignancy except for: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, localized or locally advanced prostate cancer definitively treated without recurrence or with biochemical recurrence only, or any other cancer fully treated or from which the subject has been disease-free for at least 2 years.
  • Autoimmune diseases such as rheumatoid arthritis. Vitiligo, mild psoriasis (topical therapy only) or hypothyroidism are allowed.
  • Need for systemic corticosteroids >10mg prednisone daily or equivalent alternative steroid (except physiologic dose for adrenal replacement therapy) or other immunosuppressive agents (such as cyclosporine or methotrexate) Topical and inhaled corticosteroids are allowed if medically needed.
  • Any history of organ allografts
  • Any history of HIV, hepatitis B or hepatitis C infection

Locations

  • University of California San Diego, Moores Cancer Center accepting new patients
    San Diego California 92093 United States
  • University of California San Francisco/Helen Diller Family Comprehensive Cancer Center accepting new patients
    San Francisco California 94158 United States

Lead Scientists at UC Cancer

  • Rana McKay, M.D. (ucsd)
    Associate Clinical Professor, Medicine. Authored (or co-authored) 108 research publications.
  • Jonathan Chou, M.D., Ph.D. (ucsf)
    I am a physician-scientist broadly interested in translational oncology and am currently an Instructor in the Division of Hematology/Oncology and postdoctoral research fellow in the Feng Lab (http://fenglaboratory.com/) and Ashworth Lab.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of Michigan Rogel Cancer Center
ID
NCT03570619
Phase
Phase 2
Study Type
Interventional
Last Updated