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

Study summary

The primary purpose of this study is to determine the antitumor activity of enfortumab vedotin as measured by confirmed objective response rate (ORR) per RECIST v1.1.

This study will also assess other measures of antitumor activity; overall survival (OS); as well as the safety and tolerability of enfortumab vedotin for cohorts 1 to 8 and enfortumab vedotin + pembrolizumab in cohort 9.

Additional Study Details

Phase

Phase 2

Product

enfortumab vedotin

Product

enfortumab vedotin

pembrolizumab

Type

Interventional

Masking

None (Open Label)

Enrollment number

329

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Locations

Active, not recruiting

Site JP81002

Koto, Tokyo, Japan

Completed

Gettysburg Cancer Center

Gettysburg, PA, United States, 17375

Completed

Seattle Cancer Care Alliance

Seattle, WA, United States, 98109

Active, not recruiting

Site JP81004

Nagoya, Aichi, Japan

Active, not recruiting

Site JP81003

Chuo, Tokyo, Japan

Active, not recruiting

New York University Langone Health

New York, NY, United States, 10016

Completed

Piedmont Hospital

Atlanta, GA, United States, 30318

Active, not recruiting

Site JP81001

Kashiwa, Chiba, Japan

Completed

Mary Crowley Research Center

Dallas, TX, United States, 75230

Completed

Arizona Oncology

Tucson, AZ, United States, 85711

Completed

University of Kansas

Fairway, KS, United States, 66205

Active, not recruiting

Site JP81006

Nagaizumi, Shizuoka, Japan

Completed

University of Colorado

Aurora, CO, United States, 80045

Completed

Comprehensive Cancer Centers of Nevada

Las Vegas, NV, United States, 89169

Completed

Indiana University Cancer Center

Indianapolis, IN, United States, 46202

Withdrawn

University of Southern California

Los Angeles, CA, United States, 90033

Withdrawn

Washington University in St. Louis

St. Louis, MO, United States, 63110

Active, not recruiting

University of Michigan

Ann Arbor, MI, United States, 48109

Active, not recruiting

Florida Cancer Specialists

Tallahassee, FL, United States, 32308

Completed

Northside Hospital

Atlanta, GA, United States, 30342

Completed

Northwestern University Medical Center

Chicago, IL, United States, 60611

Active, not recruiting

Ohio State University

Columbus, OH, United States, 43210

Active, not recruiting

Cleveland Clinic

Cleveland, OH, United States, 44195

Completed

Nebraska Methodist Hospital

Omaha, NE, United States, 68114

Active, not recruiting

Wisconsin Carbone Cancer Center

Madison, WI, United States, 53792

Completed

Florida Cancer Specialists

West Palm Beach, FL, United States, 33401

Completed

Florida Cancer Specialists

Fort Myers, FL, United States, 33901

Active, not recruiting

Site JP81005

Chuo-ku, Osaka, Japan

Active, not recruiting

Henry Ford Hospital

Detroit, MI, United States, 48202

Active, not recruiting

Rutgers Cancer Institute

New Brunswick, New Jersey, United States, 08901

Active, not recruiting

University of Chicago

Chicago, IL, United States, 60637

Active, not recruiting

Dana-Farber Cancer Institute

Boston, MA, United States, 02215

Completed

University of Texas

Houston, TX, United States, 77030

Withdrawn

Ochsner Medical Center

New Orleans, LA, United States, 70121

Withdrawn

Site CA15001

Hamilton, ON, Canada, L8V 5C2

Active, not recruiting

Site CA15003

Ottawa, ON, Canada, K1H 8L6

Completed

University of Minnesota Cancer Center

Minneapolis, MN, United States, 55455

Withdrawn

Dartmouth-Hitchcock Norris Cotton Cancer Center

Lebanon, NH, United States, 03765

Completed

Sarah Cannon Research Institute

Nashville, TN, United States, 37203

Withdrawn

University of Cincinnati

Cincinnati, OH, United States, 45219

Active, not recruiting

Site JP81007

Osaka-Sayama, Osaka, Japan

Completed

Memorial Sloan Kettering Cancer Center

New York, NY, United States, 10022

Withdrawn

Site CA15002

Vancouver, BC, Canada, V5Z 4E6

Withdrawn

Providence St. Joseph Medical Center

Burbank, CA, United States, 91505

Withdrawn

Site JP81009

Shinjuku-ku, Tokyo, Japan

Completed

Site JP81010

Okayama, Okayama, Japan

Active, not recruiting

Site JP81011

Kitaadachi-Gun, Saitama, Japan

Withdrawn

University of Nebraska

Omaha, NE, United States, 68198

Withdrawn

Site CA15005

Montreal, Quebec, Canada, H3T 1E2

Completed

University of California - San Francisco

San Francisco, CA, United States, 94158

Withdrawn

Beth Israel Deaconess Medical Center

Boston, MA, United States, 02215

Trial info

Follow Trial

Age

18+ years

Condition

Advanced/Metastatic Cancer

Sex

Female & Male

Trial Dates

Mar 2020 - Feb 2025

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Additional Study Details

Inclusion Criteria

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.
For cohort 9 only: Subject should submit archival or fresh tumor tissue sample for programmed cell death-ligand 1 (PD-L1) central testing during screening if no local PD-L1 test result is available. Central test result for PD-L1 will be required prior to subject enrollment. For cohort 9 subjects with local PD-L1 test result confirming CPS ≥ 1, archival or fresh tissue sample for exploratory analysis should be submitted within 5 days of enrollment.
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.
- absolute neutrophil count (ANC) ≥ 1.0 × 10^9/L
- platelet count ≥ 100 × 10^9/L
- hemoglobin ≥ 9 g/dL
- serum total bilirubin ≤ 1.5 × upper limit of normal (ULN) or ≤ 3 × ULN for subjects with Gilbert’s disease
- creatinine clearance (CrCl) ≥ 30 mL/min as estimated per institutional standards or as measured by 24-hour urine collection (glomerular filtration rate [GFR] can also be used instead of CrCl).
- alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN
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-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 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: second-line or later 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.

Cohort 9: 1L HNSCC

Subject has histologically- or cytologically-confirmed head and neck squamous cell carcinoma.

a. 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 9.

Subject has recurrent or metastatic disease that is incurable by local therapies.
Subject’s tumor sample has PD-L1 combined positive score (CPS) of ≥ 1 as determined by local or central IHC testing.
Subject has had no prior systemic therapy administered with the exception of systemic therapy completed > 6 months prior if given as part of multimodal treatment for locally advanced disease. Subjects who have received a PD-1 or PD-L1 inhibitor in the curative setting are eligible if it has been at least 12 months since last dose of the anti PD-L1 agent.
Subject has ANC ≥ 1.5 × 10^9/L.
International normalized ratio (INR) OR prothrombin time (PT) and activated partial thromboplastin (aPTT) both ≤ 1.5 × ULN unless subject is receiving anticoagulant therapy as long as PT or aPTT is within the therapeutic range of intended use of anticoagulants. PTT may be used if local lab is unable to perform aPTT.
For subjects with oropharynx tumors, subject has results from testing of HPV status by p16 testing.

Exclusion Criteria

For All Cohorts:

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. Routine antimicrobial prophylaxis is permitted.
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.

Cohort 9: 1L HNSCC

Had PD within 6 months of completion of curatively intended systemic treatment for

locoregionally advanced HNSCC.

Has had an allogeneic tissue/solid organ transplant.

Has severe hypersensitivity (≥grade 3) to pembrolizumab and/or any of its excipients.

Has a history of (non-infectious) pneumonitis / interstitial lung disease that required steroids or has current pneumonitis / interstitial lung disease.
Has a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
Has a life expectancy of less than 3 months and/or has rapidly progressing disease (e.g. tumor bleeding, uncontrolled tumor pain) in the opinion of the treating investigator.
Active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).

a. Replacement therapy (e.g., thyroxine, insulin, physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.

b. Brief (<7 days) use of systemic corticosteroids is allowed when use is considered standard of care.

c. Subjects with vitiligo, psoriasis, type 1 diabetes mellitus, hypothyroidism, or resolved childhood asthma/atopy will not be excluded.

d. Subjects requiring intermittent use of bronchodilators, inhaled steroids, or local

steroid injections will not be excluded.

e. Subjects with hypothyroidism that is stable with hormone replacement or Sjögren's syndrome will not be excluded.

Has an active infection requiring systemic therapy.
Has received prior therapy with an anti-PD-1 or anti-PD-L1 agent in the recurrent/metastatic setting. If anti-PD-1 or anti-PD-L1 agent was given as part of curative intent therapy, it must be at least 1 year since last dose.
Has received a live vaccine within 30 days of planned start of study therapy. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette Guérin, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.
Subject has active tuberculosis

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While some clinical trials may focus on more advanced cancers, many trials are open to patients at various stages of their cancer. Each study has rules about who can take part. For example, only patients in a certain age group or those who have a certain type of tumor may be able to join.

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In cancer clinical trials, a placebo is only used if there is no other treatment for that type of cancer. This helps compare an investigational treatment to the placebo. Placebos are rarely used in cancer trials because the best available treatment, called the “standard of care”, is usually given instead.

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

Study summary

Additional Study Details

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