Lung Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

200

Study ID:

NCT04993677

Recruitment Status:

Recruiting

Sponsor:

Seagen Inc.

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There are 29 Locations for this study

See Locations Near You

Highlands Oncology Group
Springdale Arkansas, 72762, United States More Info
Katie Guenther
Contact
479-334-2430
[email protected]
J. Thaddeus Beck
Principal Investigator
The Angeles Clinic and Research Institute
Los Angeles California, 90025, United States More Info
Saba Mukarram
Contact
310-231-2181
[email protected]
Omid Hamid
Principal Investigator
California Pacific Medical Center Research Institute/Sutter Medical Centre
San Francisco California, 94115, United States More Info
Emilia Janiczek
Contact
[email protected]
Kevin Kim
Principal Investigator
University of California at San Francisco
San Francisco California, 94134, United States More Info
Michael Wong
Contact
415-514-6714
[email protected]
Adil Daud
Principal Investigator
Florida Cancer Specialists - South Region
Fort Myers Florida, 33901, United States More Info
Florida Cancer Specialists - South Region Research Office Inbox
Contact
Ivor Percent
Principal Investigator
Florida Cancer Specialists - North Region
Saint Petersburg Florida, 33705, United States More Info
Florida Cancer Specialists - North Region Research Office Inbox
Contact
727-216-1143
[email protected]
Vijay Patel
Principal Investigator
University Cancer & Blood Center, LLC
Athens Georgia, 30607, United States More Info
Nikki Cooper
Contact
706-353-2990
[email protected]
Kuang Chang
Principal Investigator
Rush University Medical Center
Chicago Illinois, 60612, United States More Info
Timothy Kuzel
Principal Investigator
Community Health Network
Indianapolis Indiana, 46250, United States More Info
Elizabeth Glowinski
Contact
[email protected]
Natraj Ammakkanavar
Principal Investigator
American Oncology Networks LLC
Baton Rouge Louisiana, 70809, United States More Info
Michael Castine
Principal Investigator
Allina Health Cancer Institute
Minneapolis Minnesota, 55047, United States More Info
Lynne Schroeder
Contact
763-236-5619
[email protected]
Thomas Amatruda
Principal Investigator
University of Minnesota
Minneapolis Minnesota, 55455, United States More Info
Stephanie Soper
Contact
612-626-6646
[email protected]
Evidio Domingo-Musibay
Principal Investigator
Regions Cancer Care Center
Saint Paul Minnesota, 55101, United States More Info
Jacquelyn Christenson
Contact
651-254-3602
[email protected]
Arkadiusz Dudek
Principal Investigator
Morristown Medical Center/ Carol G. Simon Cancer Center
Morristown New Jersey, 07960, United States More Info
Maureen Nowakowski
Contact
973-971-5569
[email protected]
Charles Farber
Principal Investigator
Duke University Medical Center
Durham North Carolina, 27710, United States More Info
Carol Ann Wiggs
Contact
919-684-0281
[email protected]
April Salama
Principal Investigator
Gabrail Cancer Center Research, LLC
Canton Ohio, 44718, United States
Cleveland Clinic - Taussig Cancer Institute
Cleveland Ohio, 44195, United States More Info
Cleveland Clinic Cancer Answer Line
Contact
866-223-8100
[email protected]
Dale Shepard
Principal Investigator
Kaiser Permanente Oregon
Portland Oregon, 97227, United States More Info
Michelle Jones
Contact
503-331-6540
[email protected]
Sandeep Mashru
Principal Investigator
Thomas Jefferson University
Philadelphia Pennsylvania, 19107, United States More Info
Carolyn Palumbro
Contact
215-955-0109
[email protected]
Marlana Orloff
Principal Investigator
Tennessee Oncology-Nashville/Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States More Info
Sharon Rector
Contact
615-329-7274
[email protected]
Meredith McKean
Principal Investigator
University of Texas Southwestern/Simmons Cancer Center
Dallas Texas, 75390, United States More Info
Tammy Ricklefs
Contact
214-645-1853
[email protected]
Sanjay Chandrasekaran
Principal Investigator
MD Anderson Cancer Center / University of Texas
Houston Texas, 77030, United States More Info
Anna Vardeleon
Contact
[email protected]
Sapna Patel
Principal Investigator
Carbone Cancer Center / University of Wisconsin
Madison Wisconsin, 53792, United States More Info
Cancer Connect
Contact
800-622-8922
Vincent Ma
Principal Investigator
CHU de Quebec-Universite Laval
Quebec , G1R 2, Canada More Info
Olivier Dumas
Principal Investigator
Hopital Foch
Suresnes Other, 92150, France More Info
Jaafar Bennouna
Principal Investigator
Universitatsklinikum Heidelberg
Heidelberg Other, 69120, Germany More Info
Jessica Hassel
Principal Investigator
START Madrid-CIOCC_Hospital HM Sanchinarro
Madrid Other, 28050, Spain More Info
Emiliano Calvo
Principal Investigator
Hospital Clinico Universitario de Valencia
Valencia Other, 46010, Spain More Info
Andres Manuel Cervantes Ruiperez
Principal Investigator
Karolinska University Hospital
Stockholm Other, 171 7, Sweden More Info
Jeffrey Yanchin
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

200

Study ID:

NCT04993677

Recruitment Status:

Recruiting

Sponsor:


Seagen Inc.

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