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Biomarker-Driven Therapy With Nivolumab and Ipilimumab in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Expressing AR-V7
Phase 2 trial testing Ipilimumab in Prostate Cancer in 32 participants. Completed in 6 October 2021.
| Lead sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 32 |
| Start date | 15 March 2016 |
| Primary completion | 3 December 2020 |
| Estimated completion | 6 October 2021 |
| Sites | 1 location across United States |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — full company profile →
18 and older, male only, with Prostate Cancer or Recurrent Prostate Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of participants with greater than 50% decline in PSA from start of treatment, sustained for \>= 4 weeks, as defined by Prostate Cancer Working Group 2 (PCWG2) criteria.
| Group | Value | 95% CI |
|---|---|---|
| Nivolumab and Ipilimumab | 2 | |
| Enzalutamide Plus Nivolumab and Ipilimumab | 0 |
Number of participants with PFS \>= 24 weeks. PFS is described as number of weeks from start of treatment until first evidence of clinical radiographic progression, or death.
| Group | Value | 95% CI |
|---|---|---|
| Nivolumab and Ipilimumab | 3 | |
| Enzalutamide Plus Nivolumab and Ipilimumab | 4 |
Number of participants experiencing Grade 3-4 adverse events, Grade 3-4 immune-related AEs (irAEs), as defined by National Cancer Institute (NIH) CTCAE version 4.0
| Group | Value | 95% CI |
|---|---|---|
| Nivolumab and Ipilimumab | 7 | |
| Enzalutamide Plus Nivolumab and Ipilimumab | 8 |
| Group | Value | 95% CI |
|---|---|---|
| Nivolumab and Ipilimumab | 5 | |
| Enzalutamide Plus Nivolumab and Ipilimumab | 7 |
| Group | Value | 95% CI |
|---|---|---|
| Nivolumab and Ipilimumab | 6 | |
| Enzalutamide Plus Nivolumab and Ipilimumab | 3 |
Number of participants with complete response (CR) or partial response (PR) in measurable soft tissue lesions, as defined by RECIST version 1.1
| Group | Value | 95% CI |
|---|---|---|
| Nivolumab and Ipilimumab | 2 | |
| Enzalutamide Plus Nivolumab and Ipilimumab | 0 |
Number of months alive after start of treatment.
| Group | Value | 95% CI |
|---|---|---|
| Nivolumab and Ipilimumab | 8.2 | 5.5 – 10.4 |
| Enzalutamide Plus Nivolumab and Ipilimumab | 14.2 | 8.5 – NA |
Number of months from start of treatment until first evidence of progression, as defined by based on RECIST version 1.1 and PCWG2
| Group | Value | 95% CI |
|---|---|---|
| Nivolumab and Ipilimumab | 3.7 | 2.8 – 7.5 |
| Enzalutamide Plus Nivolumab and Ipilimumab | 2.9 | 1.3 – 5.8 |
Number of months until \>= 25% or \>=2 ng/mL increase in PSA, as defined per PCWG2 criteria
| Group | Value | 95% CI |
|---|---|---|
| Nivolumab and Ipilimumab | 3.0 | 2.1 – NA |
| Enzalutamide Plus Nivolumab and Ipilimumab | 2.7 | 2.1 – 5.9 |
Time frame: up to 3 years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Nivolumab and Ipilimumab | Enzalutamide Plus Nivoluma… |
|---|---|---|---|
| intracranial hemorrhage | Nervous system disorders | — | — |
| dyspnea | Respiratory, thoracic and mediastinal disorders | — | — |
| pneumonitis | Respiratory, thoracic and mediastinal disorders | — | — |
| chronic subdural hematoma | Vascular disorders | — | — |
| elevated bilirubin | Investigations | — | — |
| hepatitis | Infections and infestations | — | — |
| musculoskeletal pain | Musculoskeletal and connective tissue disorders | — | — |
| elevated liver function test | Hepatobiliary disorders | — | — |
| allergic reaction to amoxicillin | Injury, poisoning and procedural complications | — | — |
| diarrhea | Gastrointestinal disorders | — | — |
| generalized weakness | General disorders | — | — |
| vomiting | Gastrointestinal disorders | — | — |
| nausea | Gastrointestinal disorders | — | — |
| infusion reaction | Injury, poisoning and procedural complications | — | — |
| fever | General disorders | — | — |
| lactate elevation | Investigations | — | — |
| expressive aphasia | Psychiatric disorders | — | — |
| dermatitis | Skin and subcutaneous tissue disorders | — | — |
| eosinophilia | Investigations | — | — |
| hyperglycemia | Metabolism and nutrition disorders | — | — |
| Addison's disease | Endocrine disorders | — | — |
| hepatic cyst | Hepatobiliary disorders | — | — |
| immune related colitis | Gastrointestinal disorders | — | — |
| Hypophysitis | Endocrine disorders | — | — |
| central adrenal insufficiency | Endocrine disorders | — | — |
| Reaction | System | Nivolumab and Ipilimumab | Enzalutamide Plus Nivoluma… |
|---|---|---|---|
| fatigue | General disorders | — | — |
| aspartate transaminase increased | Investigations | — | — |
| anemia | Blood and lymphatic system disorders | — | — |
| hematocrit count decreased | Blood and lymphatic system disorders | — | — |
| platelet count decreased | Blood and lymphatic system disorders | — | — |
| anorexia | Metabolism and nutrition disorders | — | — |
| pruritus | Skin and subcutaneous tissue disorders | — | — |
| musculoskeletal pain | Musculoskeletal and connective tissue disorders | — | — |
| rash | Skin and subcutaneous tissue disorders | — | — |
| cough | Respiratory, thoracic and mediastinal disorders | — | — |
| amylase increased | Investigations | — | — |
| constipation | Gastrointestinal disorders | — | — |
| edema | General disorders | — | — |
| lipase increased | Investigations | — | — |
| diarrhea | Gastrointestinal disorders | — | — |
| hypothyroidism | Endocrine disorders | — | — |
| Alkaline phosphatase increased | Hepatobiliary disorders | — | — |
| Alanine Aminotransferase increased | Investigations | — | — |
| dyspnea | Respiratory, thoracic and mediastinal disorders | — | — |
| vomiting | Gastrointestinal disorders | — | — |
| nausea | Gastrointestinal disorders | — | — |
| creatine increased | Investigations | — | — |
| dysgeusia | Nervous system disorders | — | — |
| generalized weakness | General disorders | — | — |
| leg weakness | General disorders | — | — |
| difficulty urinating | Renal and urinary disorders | — | — |
| lymphocyte count decreased | Investigations | — | — |
| pain abdomen | Gastrointestinal disorders | — | — |
| thromboembolic event | Vascular disorders | — | — |
| decreased T3Free | Investigations | — | — |
| dry mouth | Gastrointestinal disorders | — | — |
| Thyroid-stimulating hormone increased | Endocrine disorders | — | — |
| hyperthyroidism | Endocrine disorders | — | — |
| colitis | Gastrointestinal disorders | — | — |
| gastroesophageal reflux disease | Gastrointestinal disorders | — | — |
| weight loss | Investigations | — | — |
| fever | General disorders | — | — |
| gross hematuria | Renal and urinary disorders | — | — |
| pneumonitis | Respiratory, thoracic and mediastinal disorders | — | — |
| total bilirubin increased | Investigations | — | — |
Most-reported serious reactions: intracranial hemorrhage, dyspnea, pneumonitis, chronic subdural hematoma, elevated bilirubin, hepatitis, musculoskeletal pain, elevated liver function test.
Data from ClinicalTrials.gov NCT02601014 adverse events section.
This phase II trial studies how well nivolumab and ipilimumab work in treating patients with hormone-resistant prostate cancer that has spread to other places in the body and express androgen receptor-variant-7 (AR-V7). Tumor cells expressing AR-V7 has been shown to be resistant to hormone therapy and some chemotherapy in patients with prostate cancer. Biomarker-driven therapy, such as nivolumab and ipilimumab, may work by blocking key biomarkers or proteins that help tumor cells to escape the immune system surveillance and this may help the immune system to kill tumor cells that express AR-V7.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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