Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of SEA-CD40 Given With Other Drugs in Cancers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04993677
Recruitment Status : Recruiting
First Posted : August 6, 2021
Last Update Posted : November 8, 2021
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Seagen Inc.

Brief Summary:

This trial is being done to see if an experimental drug (SEA-CD40) works when it's given with other cancer drugs to treat some types of cancer. It will also study side effects from the drug.

There are 2 parts in this trial. In one part, participants have melanoma that has come back after treatment or can't be removed by surgery. Participants in this part will get SEA-CD40 and pembrolizumab. In the other part, participants have non-small cell lung cancer (NSCLC) that has spread through their body. These participants will get SEA-CD40, pembrolizumab, carboplatin, and pemetrexed.


Condition or disease Intervention/treatment Phase
Melanoma Carcinoma, Non-Small- Cell Lung Drug: SEA-CD40 Drug: pembrolizumab Drug: pemetrexed Drug: carboplatin Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Phase 2 Basket Study of SEA-CD40 Combination Therapies in Advanced Malignancies
Actual Study Start Date : October 6, 2021
Estimated Primary Completion Date : October 31, 2024
Estimated Study Completion Date : October 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: Melanoma Arm
SEA-CD40 + pembrolizumab
Drug: SEA-CD40
Given into the vein (IV; intravenously); schedule is cohort-specific

Drug: pembrolizumab
Given by IV; schedule is cohort-specific.
Other Name: Keytruda

Experimental: NSCLC Arm
SEA-CD40 + pembrolizumab + pemetrexed + carboplatin
Drug: SEA-CD40
Given into the vein (IV; intravenously); schedule is cohort-specific

Drug: pembrolizumab
Given by IV; schedule is cohort-specific.
Other Name: Keytruda

Drug: pemetrexed
Given by IV on Day 1 of each 21-day cycle.
Other Name: Alimta

Drug: carboplatin
Given by IV on Day 1 of Cycles 1-4. Each cycle will be 21 days long.
Other Name: Paraplatin




Primary Outcome Measures :
  1. Confirmed Objective Response Rate (ORR) [ Time Frame: Duration of treatment, approximately 2 years ]
    The proportion of subjects who achieve a confirmed complete response (CR) or partial (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by the investigator.


Secondary Outcome Measures :
  1. Incidence of adverse events (AEs) [ Time Frame: From start of treatment to 30-37 days after last dose, approximately 2 years ]
    Any untoward medical occurrence in a subject or clinical investigational subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

  2. Incidence of laboratory abnormalities [ Time Frame: From start of treatment to 30-37 days after last dose, approximately 2 years ]
    To be summarized using descriptive statistics

  3. Incidence of dose alterations [ Time Frame: Duration of treatment, approximately 2 years ]
    To be summarized using descriptive statistics

  4. Disease control rate (DCR) per investigator assessment [ Time Frame: From start of treatment until completion of response assessment, approximately 4 years ]
    The proportion of subjects 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.

  5. Duration of response (DOR) per investigator assessment [ Time Frame: From start of treatment until completion of response assessment, approximately 4 years ]
    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

  6. Progression-free survival (PFS) per investigator assessment [ Time Frame: From start of treatment until completion of response assessment, approximately 4 years ]
    The time from the start of study treatment to the first documentation of PD by RECIST v1.1 or death due to any cause

  7. Overall survival (OS) [ Time Frame: Duration of study, approximately 4 years ]
    The time from the start of study treatment to date of death due to any cause



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed unresectable malignancy defined as one of the following:

    • Cohort 1: Relapsed and/or refractory metastatic melanoma

      • Uveal/ocular melanoma is excluded
      • Must have progressed on treatment with an anti-PD-(L)1 mAb. PD-(L)1 treatment progression is defined as meeting all of the following criteria:
  • Has received at least 2 doses of an approved anti-PD-(L)1 mAb
  • Has demonstrated disease progression after PD-(L)1 as defined by RECIST v1.1.
  • Progressive disease has been documented within 12 weeks from the last dose of anti- PD-(L)1 mAb
  • Last dose of anti-PD-(L)1 must have been within 90 days prior to enrollment

    • Cohort 2: Metastatic uveal melanoma

      • Must not have received prior treatment for advanced or metastatic disease except for prior adjuvant/neoadjuvant immunotherapy
      • No prior regional, liver-directed therapy
    • Cohort 3: Metastatic PD-(L)1-naïve melanoma

      • Uveal/ocular melanoma is excluded
      • Must not have received prior treatment for advanced or metastatic disease except for prior adjuvant/neoadjuvant immunotherapy.
      • Participants with BRAF mutation, prior BRAF/MEK targeted therapy is allowed if completed 4 weeks prior to first dose of study treatment.
    • Cohorts 4 and 5: Non-squamous NSCLC

      • Participants must have stage IV disease per AJCC 8th edition
      • No known driver mutations/alterations mutation for which targeted therapy is available
      • Must have non-squamous histology.
      • No prior therapy for metastatic disease
      • No prior treatment with anti-PD-(L)1 or PD-L2 agent or an antibody targeting other immuno-regulatory receptors or mechanisms
  • Able to provide archival tumor tissue from locations not radiated prior to biopsy
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
  • Measurable disease per RECIST v1.1 at baseline

Exclusion Criteria:

  • History of another malignancy within 3 years of first dose of study drug
  • Active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Previous exposure to CD40-targeted therapy
  • Currently on chronic systemic steroids in excess of physiologic replacement
  • Has had an allogeneic tissue/solid organ transplant.
  • History of autoimmune disease that has required systemic treatment in the past 2 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04993677


Contacts
Layout table for location contacts
Contact: Seagen Trial Information Support 866-333-7436 clinicaltrials@seagen.com

Locations
Layout table for location information
United States, Arkansas
Highlands Oncology Group Recruiting
Springdale, Arkansas, United States, 72762
Contact: Allie Pittman       apittman@hogonc.com   
Principal Investigator: J. Thaddeus Beck         
United States, California
Angeles Clinic and Research Institute, The Recruiting
Los Angeles, California, United States, 90025
Contact: Saba Mukarram       smukarram@theangelesclinic.org   
Principal Investigator: Omid Hamid         
United States, Florida
Florida Cancer Specialists - North Region Recruiting
Saint Petersburg, Florida, United States, 33705
Contact: Wendy White       wwhite@flcancer.com   
United States, Minnesota
Virginia Piper Cancer Institute Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Lynne Schroeder       lynne.schroeder@allina.com   
Principal Investigator: Thomas Amatruda         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Carol Ann Wiggs       carolann.wiggs@duke.edu   
United States, Ohio
Gabrail Cancer Center Research, LLC Recruiting
Canton, Ohio, United States, 44718
Principal Investigator: Nashat Gabrail         
Cleveland Clinic - Taussig Cancer Center Recruiting
Cleveland, Ohio, United States, 44195
Contact: Kierstyn Hayden       HAYDENK2@ccf.org   
United States, Tennessee
Tennessee Oncology-Nashville/Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Sharon Rector       Sharon.Rector@sarahcannon.com   
United States, Texas
MD Anderson Cancer Center / University of Texas Recruiting
Houston, Texas, United States, 77030-4095
Contact: Anna Vardeleon       agvardeleon@mdanderson.org   
Principal Investigator: Sapna Patel         
Sponsors and Collaborators
Seagen Inc.
Merck Sharp & Dohme Corp.
Investigators
Layout table for investigator information
Study Director: Jonathan Hayman, MD Seagen Inc.
Layout table for additonal information
Responsible Party: Seagen Inc.
ClinicalTrials.gov Identifier: NCT04993677    
Other Study ID Numbers: SGNS40-002
KEYNOTE-C86 ( Other Identifier: Merck Sharp & Dohme Corp )
First Posted: August 6, 2021    Key Record Dates
Last Update Posted: November 8, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Seagen Inc.:
Relapsed melanoma
Refractory melanoma
Metastatic uveal melanoma
Metastatic PD-(L)1-naïve melanoma
Non-squamous NSCLC
NSCLC
Non-small cell lung cancer
Seattle Genetics
Additional relevant MeSH terms:
Layout table for MeSH terms
Melanoma
Carcinoma, Non-Small-Cell Lung
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carboplatin
Pembrolizumab
Pemetrexed
Antineoplastic Agents
Antineoplastic Agents, Immunological
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors