RECRUITING

Enfortumab Vedotin As Monotherapy in Patients with Metastatic Castration-Resistant Prostate Cancer

Conditions

Metastatic Castration-resistant Prostate Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is an open-label, phase II umbrella trial assessing the anti-tumor activity of enfortumab alone and in combination with other anti-cancer agents in subjects with metastatic castration-resistant prostate cancer. The trial will open to enrollment in Cohort A, enfortumab monotherapy. Additional cohorts may be added as new drug combinations are identified.

Official Title

A Phase 2 Umbrella Protocol of Enfortumab Vedotin As Monotherapy and Combined with Other Agents in Patients with Metastatic Castration-Resistant Prostate Cancer

Quick Facts

Study Start:2022-02-03

Study Completion:2027-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04754191

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Male subject aged ≥ 18 years. * Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology. * Diagnosis of metastatic or locally advanced, inoperable disease that cannot be treated with definitive intent * Castrate levels of testosterone as defined as \< 50 ng/dL (1.73 nmol/L). * Prior treatment with at least three or more cycles of taxane therapy (docetaxel or cabazitaxel). * Prior treatment with at least one prior Novel Hormone Therapy (NHT), defined as second-generation antiandrogen therapies that include but are not limited to abiraterone acetate, enzalutamide, apalutamide, and darolutamide. * Subject has received or refused therapies which have shown to improve overall survival and are recommended per NCCN guidelines prior to enrollment in trial. Such agents include but are not limited to docetaxel, cabazitaxel, sipuleucel-T, olaparib, rucaparib, radium-223 and lutetium (177Lu) vipivotide tetraxetan depending on patient eligibility. * Had disease progression on or after NHT prior to enrolling in the study. * ECOG Performance Status ≤ 2. * Adequate organ function as defined as: * Hematologic: * White blood cell count (WBC) ≥ 2000/mm3 * Absolute neutrophil count (ANC) ≥ 1500/mm3 * Platelet count ≥ 100,000/mm3 * Hemoglobin ≥ 9g/dL * Hepatic: * Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN) unless there is a known history of Gilbert's syndrome. * AST(SGOT)/ALT(SGPT) ≤ 5 × institutional ULN * Renal: * Estimated creatinine clearance ≥ 30 mL/min by Cockcroft-Gault formula: * Highly effective contraception throughout the study as described in Section 7.4. * Discontinued all previous treatments for cancer (except androgen-deprivation therapy and bone loss prevention treatment) 28 days prior to starting study therapy. * Recovery to baseline or ≤ Grade 1 CTCAE v 5.0 from toxicities related to any prior treatments, unless AE(s) are clinically non-significant and/or stable on supportive therapy as determined by the treating physician. * Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.	* Prior or concurrent malignancy (other than adenocarcinoma of the prostate). Note: Patients with prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial as approved by the Principal Investigator. * The subject has an uncontrolled, significant intercurrent or recent illness that would preclude safe study participation. * Clinically significant cardiovascular disease: myocardial infarction (\<6 months prior to enrollment), unstable angina, congestive heart failure (\> New York Heart Association Classification Class IIB) or a serious cardiac arrhythmia requiring medication. * Known HIV infection with a detectable viral load at the time of screening. Note: Patients on effective antiretroviral therapy with an undetectable viral load at the time of screening are eligible for this trial. * Known chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection with a detectable viral load. * Live attenuated vaccinations within ≤ 4 weeks of the first study therapy and while on trial is prohibited. * Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v5.0 Grade ≥ 3). * Subjects taking prohibited medications as described in Section 6.3. A washout period of prohibited medications for a period of at least 5 half-lives or as clinically indicated should occur prior to the start of treatment.

Inclusion Criteria

Exclusion Criteria

* Male subject aged ≥ 18 years.
* Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology.
* Diagnosis of metastatic or locally advanced, inoperable disease that cannot be treated with definitive intent
* Castrate levels of testosterone as defined as \< 50 ng/dL (1.73 nmol/L).
* Prior treatment with at least three or more cycles of taxane therapy (docetaxel or cabazitaxel).
* Prior treatment with at least one prior Novel Hormone Therapy (NHT), defined as second-generation antiandrogen therapies that include but are not limited to abiraterone acetate, enzalutamide, apalutamide, and darolutamide.
* Subject has received or refused therapies which have shown to improve overall survival and are recommended per NCCN guidelines prior to enrollment in trial. Such agents include but are not limited to docetaxel, cabazitaxel, sipuleucel-T, olaparib, rucaparib, radium-223 and lutetium (177Lu) vipivotide tetraxetan depending on patient eligibility.
* Had disease progression on or after NHT prior to enrolling in the study.
* ECOG Performance Status ≤ 2.
* Adequate organ function as defined as:
* Hematologic:
* White blood cell count (WBC) ≥ 2000/mm3
* Absolute neutrophil count (ANC) ≥ 1500/mm3
* Platelet count ≥ 100,000/mm3
* Hemoglobin ≥ 9g/dL
* Hepatic:
* Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN) unless there is a known history of Gilbert's syndrome.
* AST(SGOT)/ALT(SGPT) ≤ 5 × institutional ULN
* Renal:
* Estimated creatinine clearance ≥ 30 mL/min by Cockcroft-Gault formula:
* Highly effective contraception throughout the study as described in Section 7.4.
* Discontinued all previous treatments for cancer (except androgen-deprivation therapy and bone loss prevention treatment) 28 days prior to starting study therapy.
* Recovery to baseline or ≤ Grade 1 CTCAE v 5.0 from toxicities related to any prior treatments, unless AE(s) are clinically non-significant and/or stable on supportive therapy as determined by the treating physician.
* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.

* Prior or concurrent malignancy (other than adenocarcinoma of the prostate). Note: Patients with prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial as approved by the Principal Investigator.
* The subject has an uncontrolled, significant intercurrent or recent illness that would preclude safe study participation.
* Clinically significant cardiovascular disease: myocardial infarction (\<6 months prior to enrollment), unstable angina, congestive heart failure (\> New York Heart Association Classification Class IIB) or a serious cardiac arrhythmia requiring medication.
* Known HIV infection with a detectable viral load at the time of screening. Note: Patients on effective antiretroviral therapy with an undetectable viral load at the time of screening are eligible for this trial.
* Known chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection with a detectable viral load.
* Live attenuated vaccinations within ≤ 4 weeks of the first study therapy and while on trial is prohibited.
* Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v5.0 Grade ≥ 3).
* Subjects taking prohibited medications as described in Section 6.3. A washout period of prohibited medications for a period of at least 5 half-lives or as clinically indicated should occur prior to the start of treatment.

Contacts and Locations

Study Contact

Susan Sharry

CONTACT

801-585-3453

susan.sharry@hci.utah.edu

Principal Investigator

Umang Swami, MD

PRINCIPAL_INVESTIGATOR

Huntsman Cancer Institute

Study Locations (Sites)

Huntsman Cancer Institute

Salt Lake City, Utah, 84112

United States

Collaborators and Investigators

Sponsor: University of Utah

Umang Swami, MD, PRINCIPAL_INVESTIGATOR, Huntsman Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-03

Study Completion Date2027-09

Study Record Updates

Study Start Date2022-02-03

Study Completion Date2027-09

Terms related to this study

Additional Relevant MeSH Terms

Metastatic Castration-resistant Prostate Cancer