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

Sponsor
Seagen Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04993677
Collaborator
Merck Sharp & Dohme LLC (Industry)
200
Enrollment
29
Locations
2
Arms
48.8
Anticipated Duration (Months)
6.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
Phase 2

Study Design

Study Type:
Interventional
Anticipated 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 :
Oct 6, 2021
Anticipated Primary Completion Date :
Oct 31, 2024
Anticipated Study Completion Date :
Oct 31, 2025

Arms and Interventions

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 Names:
  • 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 Names:
  • Keytruda

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

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Confirmed Objective Response Rate (ORR) [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) [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 [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 [Duration of treatment, approximately 2 years]

      To be summarized using descriptive statistics

    4. Disease control rate (DCR) per investigator assessment [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 [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 [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) [Duration of study, approximately 4 years]

      The time from the start of study treatment to date of death due to any cause

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Highlands Oncology Group Springdale Arkansas United States 72762
    2 The Angeles Clinic and Research Institute Los Angeles California United States 90025
    3 California Pacific Medical Center Research Institute/Sutter Medical Centre San Francisco California United States 94115
    4 University of California at San Francisco San Francisco California United States 94134
    5 Florida Cancer Specialists - South Region Fort Myers Florida United States 33901
    6 Florida Cancer Specialists - North Region Saint Petersburg Florida United States 33705
    7 University Cancer & Blood Center, LLC Athens Georgia United States 30607
    8 Rush University Medical Center Chicago Illinois United States 60612
    9 Community Health Network Indianapolis Indiana United States 46250
    10 American Oncology Networks LLC Baton Rouge Louisiana United States 70809
    11 Allina Health Cancer Institute Minneapolis Minnesota United States 55407
    12 University of Minnesota Minneapolis Minnesota United States 55455
    13 Regions Cancer Care Center Saint Paul Minnesota United States 55101
    14 Morristown Medical Center/ Carol G. Simon Cancer Center Morristown New Jersey United States 07960
    15 Duke University Medical Center Durham North Carolina United States 27710
    16 Gabrail Cancer Center Research, LLC Canton Ohio United States 44718
    17 Cleveland Clinic - Taussig Cancer Institute Cleveland Ohio United States 44195
    18 Kaiser Permanente Oregon Portland Oregon United States 97227
    19 Thomas Jefferson University Philadelphia Pennsylvania United States 19107
    20 Tennessee Oncology-Nashville/Sarah Cannon Research Institute Nashville Tennessee United States 37203
    21 University of Texas Southwestern/Simmons Cancer Center Dallas Texas United States 75390
    22 MD Anderson Cancer Center / University of Texas Houston Texas United States 77030-4095
    23 Carbone Cancer Center / University of Wisconsin Madison Wisconsin United States 53792
    24 CHU de Quebec-Universite Laval Québec Quebec Canada G1R 2J6
    25 Hopital Foch Suresnes Other France 92150
    26 Institut Catala d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet) Hospitalet de Llobregat Other Spain 08908
    27 START Madrid-CIOCC_Hospital HM Sanchinarro Madrid Other Spain 28050
    28 Hospital Clinico Universitario de Valencia Valencia Other Spain 46010
    29 Karolinska University Hospital Stockholm Other Sweden 171 76

    Sponsors and Collaborators

    • Seagen Inc.
    • Merck Sharp & Dohme LLC

    Investigators

    • Study Director: Jonathan Hayman, MD, Seagen Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Seagen Inc.
    ClinicalTrials.gov Identifier:
    NCT04993677
    Other Study ID Numbers:
    • SGNS40-002
    • KEYNOTE-C86
    First Posted:
    Aug 6, 2021
    Last Update Posted:
    Aug 17, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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:
    Melanoma
    Carcinoma, Non-Small-Cell Lung
    Carboplatin
    Pembrolizumab
    Pemetrexed

    Study Results

    No Results Posted as of Aug 17, 2022