Nivolumab + Docetaxel + ADT in mHSPC Patients With DDRD or Inflamed Tumors (NCT04126070) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Nivolumab + Docetaxel + ADT in mHSPC Patients With DDRD or Inflamed Tumors
United States60 participantsStarted 2020-05-11
Plain-language summary
This research study is studying a combination of hormonal therapy, chemotherapy, and immunotherapy as a possible treatment for metastatic hormone-sensitive prostate cancer. The names of the study drugs involved in this study are:
* Androgen deprivation therapy (ADT) with a drug of your physician's choice. This may include leuprolide (Lupron), goserelin acetate (Zoladex), or degarelix (Firmagon).
* Docetaxel
* Nivolumab
Who can participate
Age range18 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Newly diagnosed histologically confirmed prostate adenocarcinoma within 6 months prior to study registration with evidence of high-volume distant metastasis on conventional imaging
* Distant metastasis is defined by non-regional lymph node(s) metastasis (M1a), bone metastasis (M1b), and/or other site(s) of metastatic disease (M1c).
* Conventional imaging consists of CT, MRI or radionuclide bone scan
* High volume of disease is defined by presence of four or more bone lesions with at least one beyond the vertebral bodies or pelvis or any site of visceral metastasis.
* Age ≥18 years
* ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
* Subjects with ECOG performance status of 2 are only eligible if the performance status decline is attributed to metastatic prostate cancer
* Serum PSA \> 4.0 ng/mL before initiation of ADT
* Serum testosterone \> 100 ng/dL before initiation of ADT
* Subjects whose testosterone level is unknown before initiation of ADT may be allowed after discussion with Sponsor-Investigator.
* Grade ≤ 1 peripheral neuropathy, defined as asymptomatic or paresthesia and/or decreased deep tendon reflexes is allowed.
* Subjects must have adequate organ and marrow function as defined below:
* Absolute neutrophil count ≥1,500 /mcL
* Platelets ≥100,000 /mcL
* Total bilirubin ≤1.5 × institutional upper limit of normal. Exception: Subjects with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predomi…
What they're measuring
1
To determine the proportion of subjects with PSA less than or equal to 0.2 ng/mL at 7 months from start of chemoimmunotherapy in each cohort