A Study to Evaluate Enfortumab Vedotin in Subjects with Previously Treated Locally Advanced or Metastatic Malignant Solid Tumors (EV-202), Trial ID 7465-CL-202

Resumen del estudio

The primary purpose of this study is to determine the antitumor activity of enfortumab vedotin as measured by confirmed objective response rate (ORR).

This study will also assess other measures of antitumor activity; overall survival (OS); as well as the safety and tolerability of enfortumab vedotin.

Más información del estudio

Fase

Fase 2

Producto

enfortumab vedotin

Producto

enfortumab vedotin

Tipo

Interventional

Enmascaramiento

None (Open Label)

Número de inscripción

280

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A caregiver
A healthcare provider
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A patient advocate

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Correo

País/región

Alemania
Anteriormente Serbia y Montenegro
Arabia Saudita
Argelia
Argentina
Armenia
Australia
Austria
Bélgica
Bielorrusia
Bosnia y Herzegovina
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Taiwán, provincia de China
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Ubicaciones

Contáctenos

Reclutamiento

Site JP81002

Koto, Tokyo, Japón

Contáctenos

Reclutamiento

Gettysburg Cancer Center

Gettysburg, PA, Estados Unidos, 17375

Contáctenos

Reclutamiento

Seattle Cancer Care Alliance

Seattle, WA, Estados Unidos, 98109

Contáctenos

Reclutamiento

Site JP81004

Nagoya, Aichi, Japón

Contáctenos

Reclutamiento

Site JP81003

Chuo, Tokyo, Japón

Contáctenos

Reclutamiento

New York University Langone Health

New York, NY, Estados Unidos, 10016

Contáctenos

Reclutamiento

Piedmont Hospital

Atlanta, GA, Estados Unidos, 30318

Contáctenos

Reclutamiento

Site JP81001

Kashiwa, Chiba, Japón

Contáctenos

Active, not recruiting

Mary Crowley Research Center

Dallas, TX, Estados Unidos, 75230

Contáctenos

Reclutamiento

Arizona Oncology

Tucson, AZ, Estados Unidos, 85711

Contáctenos

Reclutamiento

University of Kansas

Fairway, KS, Estados Unidos, 66205

Contáctenos

Reclutamiento

Site JP81006

Nagaizumi, Shizuoka, Japón

Contáctenos

Reclutamiento

University of Colorado

Aurora, CO, Estados Unidos, 80045

Contáctenos

Reclutamiento

Comprehensive Cancer Centers of Nevada

Las Vegas, NV, Estados Unidos, 89169

Contáctenos

Reclutamiento

Indiana University Cancer Center

Indianapolis, IN, Estados Unidos, 46202

Contáctenos

Withdrawn

University of Southern California

Los Angeles, CA, Estados Unidos, 90033

Contáctenos

Withdrawn

Washington University in St. Louis

St. Louis, Mo, Estados Unidos, 63110

Contáctenos

Reclutamiento

University of Michigan

Ann Arbor, MI, Estados Unidos, 48109

Contáctenos

Reclutamiento

Florida Cancer Specialists

Tallahassee, FL, Estados Unidos, 32308

Contáctenos

Reclutamiento

Northside Hospital

Atlanta, GA, Estados Unidos, 30342

Contáctenos

Reclutamiento

Northwestern University Medical Center

Chicago, IL, Estados Unidos, 60611

Contáctenos

Reclutamiento

Ohio State University

Columbus, OH, Estados Unidos, 43210

Contáctenos

Reclutamiento

Cleveland Clinic

Cleveland, OH, Estados Unidos, 44195

Contáctenos

Reclutamiento

Nebraska Methodist Hospital

Omaha, NE, Estados Unidos, 68114

Contáctenos

Reclutamiento

Wisconsin Carbone Cancer Center

Madison, WI, Estados Unidos, 53792

Contáctenos

Reclutamiento

Florida Cancer Specialists

West Palm Beach, FL, Estados Unidos, 33401

Contáctenos

Reclutamiento

Florida Cancer Specialists

Fort Myers, FL, Estados Unidos, 33901

Contáctenos

Reclutamiento

Site JP81005

Chuo-ku, Osaka, Japón

Contáctenos

Reclutamiento

Henry Ford Hospital

Detroit, MI, Estados Unidos, 48202

Contáctenos

Reclutamiento

Rutgers Cancer Institute

New Brunswick, New Jersey, Estados Unidos, 08901

Contáctenos

Reclutamiento

University of Chicago

Chicago, IL, Estados Unidos, 60637

Contáctenos

Reclutamiento

Dana-Farber Cancer Institute

Boston, MA, Estados Unidos, 02215

Contáctenos

Reclutamiento

University of Texas

Houston, TX, Estados Unidos, 77030

Contáctenos

Reclutamiento

Ochsner Medical Center

New Orleans, LA, Estados Unidos, 70121

Contáctenos

Reclutamiento

Site CA15001

Hamilton, ON, Canadá, L8V 5C2

Contáctenos

Reclutamiento

Site CA15003

Ottawa, ON, Canadá, K1H 8L6

Contáctenos

Reclutamiento

University of Minnesota Cancer Center

Minneapolis, MN, Estados Unidos, 55455

Contáctenos

Reclutamiento

Dartmouth-Hitchcock Norris Cotton Cancer Center

Líbano, NH, Estados Unidos, 03765

Contáctenos

Reclutamiento

Sarah Cannon Research Institute

Nashville, TN, Estados Unidos, 37203

Contáctenos

Reclutamiento

University of Cincinnati

Cincinnati, OH, Estados Unidos, 45219

Contáctenos

Reclutamiento

Site JP81007

Osaka-Sayama, Osaka, Japón

Contáctenos

Reclutamiento

Memorial Sloan Kettering Cancer Center

New York, NY, Estados Unidos, 10022

Contáctenos

Reclutamiento

Site CA15002

Vancouver, BC, Canadá, V5Z 4E6

Contáctenos

Reclutamiento

Providence St. Joseph Medical Center

Burbank, CA, Estados Unidos, 91505

Contáctenos

Reclutamiento

Site JP81009

Shinjuku-ku, Tokyo, Japón

Contáctenos

Reclutamiento

Site JP81010

Okayama, Okayama, Japón

Contáctenos

Reclutamiento

Site JP81011

Kitaadachi-Gun, Saitama, Japón

Contáctenos

Reclutamiento

University of Nebraska

Omaha, NE, Estados Unidos, 68105

Contáctenos

Reclutamiento

Site CA15005

Montreal, Quebec, Canadá, H3T 1E2

Contáctenos

Reclutamiento

University of California - San Francisco

San Francisco, CA, Estados Unidos, 94158

Contáctenos

Reclutamiento

Beth Israel Deaconess Medical Center

Boston, MA, Estados Unidos, 02215

Contáctenos

Información del estudio

Estudio de seguimiento

Edad

18 años de edad en adelante

Afección

Cáncer avanzado/metastásico

Sexo

Mujer y hombre

Fechas del estudio

Mar 2020 - Apr 2024

Compartir con

Más información del estudio

Criterios de inclusión

Subject is considered an adult according to local regulation at the time of signing the informed consent form (ICF).
Subject has measurable disease by RECIST Version 1.1.
Subject has accessible archival tumor tissue from either the primary tumor or a metastatic site, for which source and availability have been confirmed prior to study treatment. If no archival tumor tissue is available, the subject will have a biopsy to obtain tumor tissue prior to study treatment. If the subject is unable to undergo a biopsy due to safety concerns, enrollment into the study must be discussed with the medical monitor.
Subject has ECOG performance status of 0 or 1.
Subject has the following baseline laboratory data. If a subject has received a recent blood transfusion, the hematology tests must be obtained ≥ 28 days after any blood transfusion.
- Recuento absoluto de neutrófilos (Absolute Neutrophil Count, ANC) ≥ 1.0 × 10^9/l
- Recuento de plaquetas ≥ 100 × 10^9/l
- Hemoglobina ≥ 9 g/dl
- serum total bilirubin ≤ 1.5 × upper limit of normal (ULN) or ≤ 3 × ULN for subjects with Gilbert’s disease
- Depuración de creatinina (Creatinine Clearance, CrCl) ≥ 30 ml/min según las estimaciones de las normas institucionales o según las mediciones de la recolección de orina de 24 horas. También puede usarse la tasa de filtración glomerular (TFG) en lugar de la CrCl.
- Alanina aminotransferasa (ALT) y aspartato aminotransferasa (AST) ≤ 3 × LSN
Subject agrees not to participate in another interventional study while receiving study treatment in the present study.
Additional contraceptive requirements exist for male and female subjects.

Disease Specific Inclusion Criteria:

Evidence of progression on or after the last regimen received.
Locally advanced or metastatic disease that is not amenable to curative intent treatment.

Cohort 1: HR+/HER2- breast cancer

Subject has evidence of radiographic progression on or after the last regimen received.
Subject has histologically- or cytologically-confirmed HR+/HER2- (estrogen receptor [ER] positive and/or progesterone receptor [PR] positive, and HER2 negative) breast cancers and are not considered a candidate for further hormonal therapy. Subject will be considered HR+ if biopsies show ≥ 1% expression of ER or PR as per current American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines.
Subject has locally advanced or metastatic disease that is not amenable to curative intent treatment.
Subject must have received a taxane or anthracycline in the neoadjuvant, adjuvant or incurable, locally advanced or metastatic setting.
- Prior cytotoxic regimen received in the neoadjuvant or adjuvant setting will count as a prior cytotoxic regimen if disease recurrence occurred during or within 6 months of completing the regimen.
Subject has progressed, relapsed, or discontinued for toxicity during or after at least 1 prior standard of care cytotoxic regimen in the incurable, unresectable locally advanced or metastatic setting, and has not received > 2 prior lines of cytotoxic therapy in the locally advanced or metastatic setting. No limit applies to endocrine therapies. Poly(ADP-ribose) polymerases (PARP) inhibitors do not count as a line of cytotoxic therapy.
Subject has progressed, relapsed, or discontinued for toxicity during or after receiving endocrine therapy or with hormonally-directed therapy with cyclin-dependent kinase (CDK) inhibitors. Prior therapy with CDK inhibitors is not required.

Cohort 2: triple negative breast cancer (TNBC)

Subject has evidence of radiographic progression on or after the last regimen received.
Subject has histologically- or cytologically-confirmed TNBC; defined as unequivocal TNBC histology (ER-negative/PR-negative/HER2-negative). This is defined by < 1% expression of ER and PR by immunohistochemistry (IHC), and that are, for HER2, either 0 to 1+ by IHC, or IHC 2+ and fluorescence in situ hybridization (FISH) negative (not amplified) as per current ASCO/CAP guidelines.
Subject has locally advanced or metastatic disease that is not amenable to curative intent treatment.
Subject must have received a taxane or anthracycline in the neoadjuvant, adjuvant or incurable, locally advanced or metastatic setting.
- Prior cytotoxic regimen received in the neoadjuvant or adjuvant setting will count as a prior cytotoxic regimen if disease recurrence occurred during or within 6 months of completing the regimen.
Subject has progressed, relapsed, or discontinued for toxicity during or after at least 1 prior standard of care cytotoxic regimen in the incurable, unresectable locally advanced or metastatic setting, and has not received > 2 prior lines of cytotoxic therapy in the locally advanced or metastatic setting. Poly(ADP-ribose) polymerases (PARP) inhibitors do not count as a line of cytotoxic therapy.
Subject has received prior therapy with an anti-programmed cell death protein-1 (PD-1) or an anti-programmed cell death-ligand 1 (PD-L1) based on subject’s tumor PD-1 or PD-L1 expression and local treatment guidelines and has progressed or discontinued treatment due to toxicity, or therapy is contraindicated for subject.

Cohort 3: squamous non-small cell lung cancer (NSCLC)

Subject has evidence of radiographic progression on or after the last regimen received.
Subject has histologically or cytologically-confirmed squamous NSCLC.
- Subjects with mixed histology NSCLC are eligible provided there is not any component of neuroendocrine histology.
- Subjects with known epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), reactive oxygen species (ROS), BRAF, or other actionable mutations are eligible if treated with mutation targeted therapy and have progressed, relapsed, or discontinued treatment due to toxicity.
Subject has locally advanced or metastatic disease that is not amenable to curative intent treatment.
Subject has progressed, relapsed, or discontinued treatment due to toxicity after 1 platinum-based standard of care regimen for locally advanced or metastatic disease, and has not received > 2 prior lines of cytotoxic anticancer therapy in the locally advanced or metastatic setting.

(a.) Subjects with locally advanced disease who previously received curative intent treatment with platinum-based standard of care regimen in the adjuvant or neoadjuvant setting or as part of concomitant chemoradiation therapy are eligible if they have progressed or relapsed within 6 months of completion.

(b.) Maintenance therapy does not constitute a new chemotherapy regimen provided there was no progression after the initial platinum-based regimen.

(c.) Changing chemotherapy agents during platinum-based treatment for the management of toxicities does not constitute a new chemotherapy regimen provided no progression had occurred while on the initial therapy.

Subject has received prior therapy with an anti-programmed cell death protein-1 (PD-1) or anti-programmed cell death-ligand 1 (PD-L1) based on subject’s tumor PD-1 or PD-L1 expression and local treatment guidelines and has progressed, relapsed, or discontinued treatment due to toxicity, or therapy is contraindicated for subject.

Cohort 4: non-squamous non-small cell lung cancer

Subject has evidence of radiographic progression on or after the last regimen received.
Subject has histologically- or cytologically-confirmed non-squamous NSCLC.
- Subjects with mixed histology NSCLC are eligible provided there is not any component of neuroendocrine histology.
- Subjects with known EGFR, ALK, ROS, BRAF, or other actionable mutations are eligible if treated with mutation targeted therapy and have progressed, relapsed, or discontinued treatment due to toxicity.
Subject has locally advanced or metastatic disease that is not amenable to curative intent treatment.
Subject has progressed, relapsed, or discontinued treatment due to toxicity after 1 platinum-based standard of care regimen for locally advanced or metastatic disease, and has not received > 2 prior lines of cytotoxic anticancer therapy in the locally advanced or metastatic setting.

(b.) Maintenance therapy does not constitute a new chemotherapy regimen provided there was no progression after the initial platinum-based regimen.

Subject has received prior therapy with an anti-PD-1 or anti-PD-L1 based on subject’s tumor PD-1 or PD-L1 expression and local treatment guidelines and has progressed, relapsed, or discontinued treatment due to toxicity, or therapy is contraindicated for subject.

Cohort 5: head and neck cancer

Subject has evidence of radiographic progression on or after the last regimen received.
Subject has histologically- or cytologically-confirmed head and neck cancer.
- Primary tumor site must arise from the oral cavity, oropharynx, hypopharynx, and larynx; tumors arising from the nasopharynx are excluded. Salivary gland tumors and/or parotid gland tumors are not eligible for Cohort 5.
Subject has locally advanced or metastatic disease that is not amenable to curative intent treatment.
Subject has progressed, relapsed, or discontinued treatment due to toxicity after 1 platinum-based standard of care regimen for locally advanced or metastatic disease, and has not received > 2 prior lines of cytotoxic anticancer therapy in the locally advanced or metastatic setting.
- Subjects with locally advanced disease who previously received curative intent treatment with platinum-based standard of care regimen in the adjuvant or neoadjuvant setting or as part of concomitant chemoradiation therapy are eligible if they have progressed or relapsed within 6 months after completion.
Subject has received prior therapy with an anti-PD-1 or anti-PD-L1 based on subject’s tumor PD-1 or PD-L1 expression and local treatment guidelines and has progressed, relapsed, or discontinued treatment due to toxicity, or therapy is contraindicated for subject.

Cohorts 6, 7 and 8: gastric or gastroesophageal junction (GEJ) or esophageal adenocarcinoma

Subject has evidence of radiographic progression on or after the last regimen received.
Subject has histologically- or cytologically-confirmed gastric, GEJ, or esophageal cancer.
Subject has locally advanced or metastatic disease that is not amenable to curative intent treatment.
Subject has progressed, relapsed, or discontinued due to toxicity after 1 platinum-based standard of care regimen for locally advanced or metastatic disease, and has not received > 2 prior lines of cytotoxic anticancer therapy in the locally advanced or metastatic setting.
- Neoadjuvant or adjuvant cytotoxic regimens will count as a prior regimen if relapsed or progressed ≤ 6 months after completion.
Subject must have received a HER2 directed therapy if known to have HER2 positive cancer.
Subject has received prior therapy with an anti-PD-1 or anti-PD-L1 based on subject’s tumor PD-1 or PD-L1 expression and local treatment guidelines and has progressed, relapsed, or discontinued treatment due to toxicity, or therapy is contraindicated for subject.

Criterios de exclusión

Subject has preexisting sensory or motor neuropathy Grade ≥ 2.
Subject has active central nervous system (CNS) metastases. Subjects with treated CNS metastases are permitted on study if all the following are true:
- CNS metastases have been clinically stable for ≥ 6 weeks prior to screening
- If requiring steroid treatment for CNS metastases, the subject is on a stable dose ≤ 20 mg/day of prednisone or equivalent for ≥ 2 weeks
- Baseline imaging scans show no evidence of new or enlarged brain metastasis
- Subject does not have leptomeningeal disease
Subject has ongoing clinically significant toxicity (Grade 2 or higher with the exception of alopecia) associated with prior treatment (including systemic therapy, radiotherapy or surgery).
Subjects with ongoing ≥ Grade 3 immunotherapy-related hypothyroidism or panhypopituitarism are excluded. Subjects with ongoing immunotherapy-related colitis, uveitis, myocarditis or pneumonitis, or subjects with other immunotherapy-related AEs requiring high doses of steroids (> 20 mg/day of prednisone or equivalent), are excluded. Subject with ≤ Grade 2 immunotherapy-related hypothyroidism or panhypopituitarism may be enrolled when well maintained/controlled on a stable dose of hormone replacement therapy (if indicated).
Subject has a history of uncontrolled diabetes mellitus within 3 months before the first dose of study treatment. Uncontrolled diabetes (within 3 months before first dose) is defined as hemoglobin A1c (HbA1c) ≥ 8% or HbA1c between 7 and < 8% with associated diabetes symptoms (polyuria or polydipsia) that are not otherwise explained. The lowest HbA1c during the screening period will be used to determine eligibility.
Subject has prior treatment with enfortumab vedotin or other monomethyl auristatin E (MMAE) based antibody-drug conjugates (ADCs).
Subject has a second malignancy diagnosed within 3 years before first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Subjects with non-melanoma skin cancer, localized prostate cancer treated with curative intent with no evidence of progression, low-risk or very low-risk (per standard guidelines) localized prostate cancer under active surveillance/watchful waiting without intent to treat, or carcinoma in situ of any type (if complete resection was performed) are allowed.
Subject is currently receiving systemic antimicrobial treatment for viral, bacterial, or fungal infection at the time of first dose of study treatment. Se permite la profilaxis antimicrobiana de rutina.
Subject has known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or active hepatitis C (e.g., hepatitis C virus [HCV] RNA [qualitative] is detected).
Subject has known history of human immunodeficiency virus (HIV) infection (HIV 1 or 2).
Subject has documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction or cardiac symptoms (including congestive heart failure) consistent with New York Heart Association Class III-IV within 6 months prior to the first dose of study drug.
Subject has major surgery within 4 weeks prior to first dose of study drug.
Subject had radiotherapy, chemotherapy, biologics, investigational agents, and/or antitumor treatment with immunotherapy that is not completed 2 weeks prior to first dose of study drug.
Subject has known hypersensitivity to enfortumab vedotin or to any excipient contained in the drug formulation of enfortumab vedotin (including histidine, trehalose dihydrate and polysorbate 20) OR subject has known hypersensitivity to biopharmaceutical produced in Chinese hamster ovary cells.
Subject has known active keratitis or corneal ulcerations. Subject with superficial punctate keratitis is allowed if the disorder is being adequately treated.
Subject has any condition which makes the subject unsuitable for study participation.

Preguntas frecuentes

¿Los estudios clínicos son solo para personas con cáncer avanzado?

Si bien algunos estudios clínicos pueden enfocarse en cánceres más avanzados, muchos estudios están abiertos para pacientes con cáncer en diferentes etapas. Cada estudio tiene reglas que establecen quiénes pueden participar. Por ejemplo, quizás solo puedan participar pacientes de un grupo de edad determinado o aquellos que tengan un tipo determinado de tumor.

¿Será necesario que interrumpa mi tratamiento actual para participar en un estudio clínico?

A veces los investigadores quieren que los participantes sigan recibiendo sus tratamientos actuales durante un estudio clínico. En otras ocasiones, es posible que deba interrumpir sus tratamientos actuales durante un tiempo. Si el tratamiento en investigación no funciona, siempre puede volver a su plan de tratamiento original.

¿Debería preocuparme la posibilidad de recibir placebo?

En los estudios clínicos oncológicos, solo se usa placebo si no hay otro tratamiento disponible para ese tipo de cáncer. Esto ayuda a comparar un tratamiento en investigación con el placebo. Los placebos rara vez se usan en estudios oncológicos, porque en su lugar generalmente se administra el mejor tratamiento disponible, que se denomina “estándar de atención”.

¿Necesito una derivación de mi médico para participar en un estudio?

Es posible que su médico no conozca todas las oportunidades de participación en estudios clínicos que usted tiene a su disposición. Hable con su médico o con otro profesional de la salud sobre la información que encuentre en relación con un estudio clínico. Podrán ayudarlo a decidir si el estudio clínico es adecuado para usted. Si no encuentra ninguna opción en este sitio web, le recomendamos que visite un registro público en línea, por ejemplo, clinicaltrials.gov para conocer los diversos estudios clínicos que están disponibles.

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A Study to Evaluate Enfortumab Vedotin in Subjects with Previously Treated Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)

Resumen del estudio

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