Phase 2
N=56
Immunotherapy in Patients With Metastatic Cancers and CDK12 Mutations
Metastatic Castration Resistant Prostate Cancer · Metastatic Cancer · Solid Tumor
Bottom Line
View on ClinicalTrials.gov: NCT03570619 ↗Enrolled (actual)
56
Serious AEs
46.4%
Results posted
Jan 2024
Primary outcome: Primary: The Proportion of Patients With CDK12 Loss of Function Metastatic CRPC That Respond to Treatment. — 2; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Nivolumab (Drug); Ipilimumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan Rogel Cancer Center
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Proportion of Patients With CDK12 Loss of Function Metastatic CRPC That Respond to Treatment. |
2; 0 | — |
| SECONDARY The Proportion of Patients That Respond to Treatment in Cohort B. |
0; 1; 0 | — |
| SECONDARY Radiographic Progression Free Survival Time (rPFS) |
166; NA; 110 | — |
| SECONDARY Progression Free Survival Time (PFS) |
213; NA; 138 | — |
| SECONDARY Duration of Therapy (DOT) |
12; 8.07; 15.86 | — |
| SECONDARY Progression Rate at 6 Months |
74; 67; 71 | — |
| SECONDARY Overall Survival Time |
273; NA; 421 | — |
| SECONDARY PSA Progression Free Survival Time |
213; 138 | — |
| SECONDARY Time to PSA Progression |
NA; NA | — |
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 and other tumor solid tumor histologies harboring loss of CDK12 function as well as monotherapy nivolumab treatment in patient with metastatic prostate cancer harboring loss of CDK12 function.
Eligibility Criteria
Inclusion Criteria
- 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 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
Data sourced from ClinicalTrials.gov (NCT03570619). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.