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Trial record 1 of 1 for:    SGNS40-002
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A Study of SEA-CD40 Given With Other Drugs in Cancers

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ClinicalTrials.gov Identifier: NCT04993677
Recruitment Status : Recruiting
First Posted : August 6, 2021
Last Update Posted : May 17, 2022
Sponsor:
Collaborator:
Merck Sharp & Dohme LLC
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

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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 participants 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 clinical investigational participant 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 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.

  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

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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
      • Participants with a targetable BRAF mutation must have been treated with, been intolerant of, or declined treatment with BRAF/MEK targeted therapy prior to study entry
    • Cohort 2: Metastatic uveal melanoma

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

      • Uveal/ocular melanoma is excluded
      • Must not have received prior treatment for advanced or metastatic disease except for prior adjuvant/neoadjuvant immunotherapy.
      • For participants with a targetable 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. If archival tumor sample is not available a fresh baseline biopsy is required.
  • 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
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Contact: Seagen Trial Information Support 866-333-7436 clinicaltrials@seagen.com

Locations
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Sponsors and Collaborators
Seagen Inc.
Merck Sharp & Dohme LLC
Investigators
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Study Director: Jonathan Hayman, MD Seagen Inc.
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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: May 17, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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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