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ESK981 and Nivolumab for the Treatment of Metastatic Castration Resistant Prostate Cancer
Phase 2 trial testing Pan-VEGFR/TIE2 Tyrosine Kinase Inhibitor CEP-11981 in Castration Levels of Testosterone in 10 participants. Terminated before completion.
| Lead sponsor | Barbara Ann Karmanos Cancer Institute |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 13 November 2019 |
| Primary completion | 1 March 2022 |
| Estimated completion | 1 March 2022 |
| Sites | 2 locations across United States |
Barbara Ann Karmanos Cancer Institute
18 and older, male only, with Castration Levels of Testosterone or Castration-Resistant 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.
Will assess PSA decline of \>= 50% from baseline (PSA50), using the Prostate Cancer Working Group 3 (PCWG3) criteria. Two-sided Wilson type 95% confidence interval (CI) estimates will be calculated.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (ESK981, Nivolumab) | 0 | 0 – 0.278 |
Time from start of treatment to death due to any cause.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (ESK981, Nivolumab) | 9.6 | 1.8 – 22.4 |
Time frame: From treatment administration to 30 days after off-treatment date, up to a maximum of 27 months. Every participant could have different AE observation duration. Patient receives treatment until one of the following off-treatment event occurs: disease progression, toxicity, investigator decision, or patient withdraw.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Treatment (ESK981, Nivolum… |
|---|---|---|
| Fall | Injury, poisoning and procedural complications | — |
| Spinal cord compression | Nervous system disorders | — |
| Transient ischemic attacks | Nervous system disorders | — |
| Reaction | System | Treatment (ESK981, Nivolum… |
|---|---|---|
| Pain | General disorders | — |
| Fatigue | General disorders | — |
| Back pain | Musculoskeletal and connective tissue disorders | — |
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | — |
| Anemia | Blood and lymphatic system disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — |
| Rash acneiform | Skin and subcutaneous tissue disorders | — |
| Chest pain - cardiac | Cardiac disorders | — |
| Hypothyroidism | Endocrine disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Edema limbs | General disorders | — |
| General disorders and administration site conditions - Other, specify | General disorders | — |
| Urinary tract infection | Infections and infestations | — |
| Fall | Injury, poisoning and procedural complications | — |
| Injury, poisoning and procedural complications - Other, specify | Injury, poisoning and procedural complications | — |
| Creatinine increased | Investigations | — |
| Lymphocyte count decreased | Investigations | — |
| Weight loss | Investigations | — |
| Anorexia | Metabolism and nutrition disorders | — |
| Metabolism and nutrition disorders - Other, specify | Metabolism and nutrition disorders | — |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | — |
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | — |
| Muscle cramp | Musculoskeletal and connective tissue disorders | — |
| Musculoskeletal and connective tissue disorder - Other, specify | Musculoskeletal and connective tissue disorders | — |
| Dizziness | Nervous system disorders | — |
| Nervous system disorders - Other, specify | Nervous system disorders | — |
| Peripheral sensory neuropathy | Nervous system disorders | — |
| Stroke | Nervous system disorders | — |
| Hoarseness | Respiratory, thoracic and mediastinal disorders | — |
| Hypertension | Vascular disorders | — |
| Hypotension | Vascular disorders | — |
Most-reported serious reactions: Fall, Spinal cord compression, Transient ischemic attacks.
Data from ClinicalTrials.gov NCT04159896 adverse events section.
This phase II trial studies the side effects of ESK981 and nivolumab and to see how well they work for the treatment of castration resistant prostate cancer that has spread to other places in the body (metastatic). ESK981 is an investigational drug that targets several important pathways that are believed to play a role in the spread of cancer. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This study is being done to see if giving ESK981 and nivolumab together works better in treating metastatic castration resistant prostate cancer compared to usual treatments.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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