Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04032704
Other study ID # SGNLVA-005
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date October 9, 2019
Est. completion date November 28, 2023

Study information

Verified date April 2024
Source Seagen Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This trial will study ladiratuzumab vedotin (LV) alone and with pembrolizumab to find out if it works to treat different types of solid tumors. It will also find out what side effects may occur. A side effect is anything the drug does besides treating cancer.


Description:

This trial is designed to assess the antitumor activity, safety, and tolerability of LV alone and with pembrolizumab, for the treatment of solid tumors. Participants with the following advanced solid tumors will be enrolled: Cohort 1: small cell lung cancer (SCLC) Cohort 2: non-small cell lung cancer-squamous (NSCLC-squamous) Cohort 3: non-small cell lung cancer-nonsquamous (NSCLC-nonsquamous) Cohort 4: head and neck squamous cell carcinoma (HNSCC) Cohort 5: esophageal squamous cell carcinoma (esophageal-squamous) Cohort 6: gastric and gastroesophageal junction (GEJ) adenocarcinoma Cohort 7: castration-resistant prostate cancer (CRPC) Cohort 8: melanoma Participants will continue to receive study treatment until disease progression, unacceptable toxicity, investigator decision, consent withdrawal, study termination by the sponsor, pregnancy, or death, whichever comes first.


Recruitment information / eligibility

Status Terminated
Enrollment 205
Est. completion date November 28, 2023
Est. primary completion date November 28, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria - All Cohorts - Measurable disease according to RECIST v1.1 as assessed by the investigator - Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1 - Cohort 1: SCLC (Parts A and B) - Must have extensive stage disease - Must have disease progression during or following prior platinum-based systemic chemotherapy for extensive stage disease; - No more than 1 prior line of cytotoxic chemotherapy for extensive disease stage - May have received prior anti-PD(L)1 therapy - Cohort 2: NSCLC-squamous (Parts A and B) - Must have unresectable locally advanced or metastatic disease - Must have disease progression during or following systemic therapy - Participants must have progressed during or after a platinum-based combination therapy administered for the treatment of metastatic disease, OR - Participants must have progressed within 6 months of last dose of platinum-based adjuvant, neoadjuvant, or definitive chemotherapy, or concomitant chemoradiation regimen for early stage or locally advanced stage disease. - Participants with known epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), reactive oxygen species (ROS), BRAF, or other actionable mutations are not eligible - No more than 1 prior line of cytotoxic chemotherapy for their advanced disease - Must have received prior anti-PD(L)1 therapy, unless contraindicated - Cohort 3: NSCLC-nonsquamous (Parts A and B) - Must have unresectable locally advanced or metastatic disease - Must have disease progression during or following systemic therapy - Participants must have progressed during or after a platinum-based combination therapy administered for the treatment of metastatic disease, OR - Participants must have progressed within 6 months of last dose of platinum-based adjuvant, neoadjuvant, or definitive chemotherapy, or concomitant chemoradiation regimen for early stage or locally advanced state disease. - Participants with known EGFR, ALK, ROS, BRAF, tropomyosin receptor kinase (TRK), or other actionable mutations are not eligible - Must have had prior platinum-based chemotherapy - No more than 1 prior line of cytotoxic chemotherapy for their advanced disease - Must have received prior anti-PD(L)1 therapy, unless contraindicated - Cohort 4: HNSCC (Parts A and B) - Must have unresectable locally recurrent or metastatic disease - Must have disease progression during or following prior line of systemic therapy - Disease progression after treatment with a platinum-containing regimen for recurrent/metastatic disease; OR - Recurrence/progression within 6 months of last dose of platinum therapy given as part of a multimodal therapy in the curative setting - No more than 1 line of cytotoxic chemotherapy for their advanced disease - May have received prior anti-PD(L)1 therapy, unless contraindicated - Cohort 5: esophageal-squamous (Parts A and B) - Must have unresectable locally advanced or metastatic disease - Must have disease progression during or following systemic therapy - Must have had prior platinum-based chemotherapy - No more than 1 line of cytotoxic chemotherapy for their advanced disease - Cohort 6: gastric and GEJ adenocarcinoma (Parts A and B) - Must have unresectable locally advanced or metastatic disease - Must have received prior platinum-based therapy - Must have disease progression during or following systemic therapy - Participants with known human epidermal growth factor receptor 2 (HER2) overexpression must have received prior HER2-targeted therapy - No more than 1 line of prior cytotoxic chemotherapy for their advanced disease - Participants may have received prior anti-PD(L)1 therapy, unless contraindicated - Cohort 7: CRPC (Part B only) - Must have histologically or cytologically confirmed adenocarcinoma of the prostate - Participants with components of small cell of neuroendocrine histology are excluded - Must have metastatic castration-resistant disease - Must have been =28 days between cessation of androgen receptor-targeted therapy and start of study treatment - Must have received no more than 1 prior line of androgen receptor-targeted therapy for metastatic castration-sensitive prostate cancer or CRPC - No prior cytotoxic chemotherapy in the metastatic CRPC setting - For participants who received cytotoxic chemotherapy in CSPC, at least 6 months must have elapsed between last dose of chemotherapy and start of study treatment - No more than 1 prior line of cytotoxic chemotherapy for CSPC - Participants with measurable disease are eligible if the following criteria are met: - A minimum starting PSA level =1.0 ng/mL - Participants with measurable soft tissue disease must have evidence of measurable soft tissue disease according to PCWG3 criteria. - Participants with known breast cancer gene (BRCA) mutations are excluded - No prior radioisotope therapy or radiotherapy to =30% of bone marrow - Cohort 8: Melanoma (Parts B and C) - Must have histologically or cytologically confirmed cutaneous malignant melanoma - Participants with mucosal, acral, or uveal melanoma are excluded - Must have locally advanced unresectable or metastatic stage disease - Must have progressive disease following anti-PD(L)1 therapy - Must have received BRAF +/- MEK inhibitor therapy if BRAF mutated (Part C) Exclusion Criteria - Active concurrent malignancy or a previous malignancy within the past 3 years - Any anticancer therapy within 3 weeks of starting study treatment. Participants who are/were on adjuvant hormonal therapy for the treatment of malignancies with negligible risk of metastases are eligible. - Known active central nervous system lesions - Any ongoing clinically significant toxicity associated with prior treatment (Grade 2 or higher) - Ongoing sensory or motor neuropathy of Grade =2 - Has received prior radiotherapy within 2 weeks of start of study treatment - History of interstitial lung disease.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
ladiratuzumab vedotin
Intravenous (into the vein; IV) infusion
pembrolizumab
200mg given by IV on Day 1 of each 21-day cycle

Locations

Country Name City State
Australia Flinders Medical Centre Bedford Park Other
Australia Townsville Cancer Center Douglas Other
Australia Peninsula and South East Oncology Frankston Other
Australia Central Coast Local Health District (Gosford and Wyong Hospitals) Gosford Other
Australia Royal Hobart Hospital Hobart Other
Australia Cabrini Malvern Other
Australia St Vincents Hospital Sydney Sydney Other
Australia Melanoma Institute Australia Wollstonecraft Other
Italy Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi Bologna Other
Italy Azienda Ospedaliero Universitaria Careggi Firenze Other
Italy ASL 3 Genovese Villa Scassi Hospital Genova Other
Italy San Luca Hospital Lucca Other
Italy Irccs Irst Meldola Other
Italy Niguarda Ca' Granda Hospital Milan Other
Italy Istituto Europeo di Oncologia Milano Other
Italy Fondazione IRCCS San Gerardo dei Tintori Monza Other
Italy Istituto Nazionale Tumori IRCCS Fondazione G. Pascale Napoli Other
Italy Policlinico Universitario Agostino Gemelli Roma Other
Italy AOUS Policlinico Le Scotte Siena Other
Korea, Republic of Dong-A University Hospital Busan Other
Korea, Republic of Chonnam National University Hwasun Hospital Hwasun Other
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si Other
Korea, Republic of Korea University Guro Hospital Seoul Other
Korea, Republic of Samsung Medical Center Seoul Other
Korea, Republic of Seoul National University Boramae Medical Center Seoul Other
Korea, Republic of Seoul National University Hospital Seoul Other
Korea, Republic of Severance Hospital, Yonsei University Health System Seoul Other
Korea, Republic of Ajou University Hospital Suwon-si Other
Korea, Republic of St. Vincent's Hospital, The Catholic University of Korea Suwon-si Other
Taiwan Taichung Veterans General Hospital Taichung Other
Taiwan National Cheng-Kung University Hospital Tainan Other
Taiwan National Taiwan University Hospital Taipei Other
Taiwan Taipei Medical University Hospital Taipei Other
United Kingdom The Beatson West of Scotland Cancer Centre Glasgow Other
United Kingdom Sarah Cannon Research Institute UK London Other
United Kingdom The Royal Marsden Hospital London Other
United Kingdom UCL Cancer Institute London Other
United Kingdom The Christie NHS Foundation Trust Manchester Other
United Kingdom The Royal Marsden Hospital (Surrey) Sutton Other
United States University of Michigan Comprehensive Cancer Center Ann Arbor Michigan
United States University of Maryland Baltimore Maryland
United States Gabrail Cancer Center Research, LLC Canton Ohio
United States Ironwood Cancer & Research Centers - Chandler Chandler Arizona
United States Erlanger Oncology and Hematology Chattanooga Tennessee
United States Northwestern University Chicago Illinois
United States IACT Health Columbus Georgia
United States Decatur Memorial Hospital - Illinois Decatur Illinois
United States San Juan Oncology Associates Farmington New Mexico
United States Fort Wayne Medical Oncology and Hematology Fort Wayne Indiana
United States Saint Francis Hospital / Bon Secours - South Carolina Greenville South Carolina
United States GenesisCare USA Jacksonville Florida
United States Comprehensive Cancer Centers of Nevada Las Vegas Nevada
United States Adventist Health White Memorial Los Angeles California
United States Joe Arrington Cancer Research and Treatment Center Lubbock Texas
United States Carbone Cancer Center / University of Wisconsin Madison Wisconsin
United States Tennessee Oncology-Nashville/Sarah Cannon Research Institute Nashville Tennessee
United States Weill Cornell Medicine New York New York
United States Eastern CT Hematology and Oncology Associates Norwich Connecticut
United States AdventHealth Cancer Institute Orlando Florida
United States Valley Hospital, The / Luckow Pavilion Paramus New Jersey
United States FirstHealth of the Carolinas Pinehurst North Carolina
United States Providence Portland Medical Center Portland Oregon
United States HealthPartners Institute Saint Louis Park Minnesota
United States Providence Medical Foundation Santa Rosa California
United States Stony Brook University Cancer Center Stony Brook New York
United States UT Health East Texas Hope Cancer Center Tyler Texas

Sponsors (2)

Lead Sponsor Collaborator
Seagen Inc. Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Australia,  Italy,  Korea, Republic of,  Taiwan,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Confirmed objective response rate (ORR) as determined by investigator according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) Confirmed ORR is defined as the proportion of participants who achieve a confirmed complete response (CR) or partial response (PR) according to RECIST v1.1 as assessed by the investigator. Up to approximately 1 year
Primary Prostate-specific antigen (PSA) response rate as determined by investigator according to Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria (Cohort 7 only) Confirmed PSA response rate is defined as the proportion of participants with a reduction from baseline PSA level of at least 50%, measured twice =3 weeks apart. Up to approximately 1 year
Secondary Number of participants with adverse events (AEs) An AE is any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Up to approximately 1 year
Secondary Disease control rate (DCR) as determined by investigator according to RECIST v1.1 DCR is defined as the proportion of participants who achieve a confirmed CR or PR according to RECIST v1.1 as assessed by the investigator, or meet the stable disease (SD) criteria at least once after start of study treatment at a minimum interval of 5 weeks or 7 weeks for prostate cancer subjects. Up to approximately 1 year
Secondary Duration of response (DOR) as determined by investigator according to RECIST v1.1 DOR is defined as the time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of progressive disease (PD) or death due to any cause, whichever comes first. Up to approximately 1 year
Secondary PSA-DOR as determined by investigator assessment (Cohort 7 only) PSA-DOR is defined as the time from the first documentation of PSA response to the first documentation of PSA progression or death, whichever comes first Up to approximately 1 year
Secondary Progression-free survival (PFS) as determined by investigator according to RECIST v1.1 PFS is defined as the time from the start of study treatment to the first documentation of PD by RECIST v1.1 or clinical PD or by PSA progression (prostate cancer cohort) or death due to any cause, whichever comes first. Up to approximately 1 year
Secondary PSA-PFS as determined by investigator assessment (Cohort 7 only) PSA-PFS is defined as the time from the start of study treatment to first occurrence of PSA progression or death, whichever comes first Up to approximately 1 year
Secondary Overall survival (OS) OS is defined as the time from the start of study treatment to date of death due to any cause. Up to approximately 1 year
Secondary Maximum observed concentration (Cmax) Pharmacokinetic (PK) endpoint of LV Up to approximately 1 year
Secondary Area under the concentration-time curve (AUC) PK endpoint of LV Up to approximately 1 year
Secondary Incidence of antitherapeutic antibodies (ATAs) to LV Up to approximately 1 year
See also
  Status Clinical Trial Phase
Recruiting NCT05613023 - A Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT Phase 3
Recruiting NCT05540392 - An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues Phase 1/Phase 2
Recruiting NCT05156424 - A Comparison of Aerobic and Resistance Exercise to Counteract Treatment Side Effects in Men With Prostate Cancer Phase 1/Phase 2
Completed NCT03177759 - Living With Prostate Cancer (LPC)
Completed NCT01331083 - A Phase II Study of PX-866 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer Phase 2
Recruiting NCT05540782 - A Study of Cognitive Health in Survivors of Prostate Cancer
Active, not recruiting NCT04742361 - Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer Phase 3
Completed NCT04400656 - PROState Pathway Embedded Comparative Trial
Completed NCT02282644 - Individual Phenotype Analysis in Patients With Castration-Resistant Prostate Cancer With CellSearch® and Flow Cytometry N/A
Recruiting NCT06305832 - Salvage Radiotherapy Combined With Androgen Deprivation Therapy (ADT) With or Without Rezvilutamide in the Treatment of Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer Phase 2
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A
Recruiting NCT05761093 - Patient and Physician Benefit/ Risk Preferences for Treatment of mPC in Hong Kong: a Discrete Choice Experiment
Completed NCT04838626 - Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection Phase 2/Phase 3
Recruiting NCT03101176 - Multiparametric Ultrasound Imaging in Prostate Cancer N/A
Completed NCT03290417 - Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer N/A
Completed NCT00341939 - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
Completed NCT01497925 - Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer Phase 1
Recruiting NCT03679819 - Single-center Trial for the Validation of High-resolution Transrectal Ultrasound (Exact Imaging Scanner ExactVu) for the Detection of Prostate Cancer
Completed NCT03554317 - COMbination of Bipolar Androgen Therapy and Nivolumab Phase 2
Completed NCT03271502 - Effect of Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy N/A