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Alkylating agents

SEA-CD40 Combination Therapy for Non-Small Cell Lung Cancer

Phase 2
Waitlist Available
Research Sponsored by Seagen Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically or cytologically confirmed unresectable malignancy defined as specified in each cohort
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up duration of study, approximately 4 years
Awards & highlights

Study Summary

This trial is testing an experimental drug to see if it works with other cancer drugs to treat some types of cancer, and to study side effects.

Who is the study for?
This trial is for adults with certain types of cancer, like melanoma that's returned or can't be surgically removed, and NSCLC that has spread. They must not have had CD40-targeted therapy before, no other cancers in the last 3 years, no autoimmune diseases treated in the past 2 years, and they shouldn't be on high doses of steroids or have active brain metastases.Check my eligibility
What is being tested?
The study tests an experimental drug called SEA-CD40 combined with pembrolizumab for melanoma patients; and SEA-CD40 with pembrolizumab, carboplatin, and pemetrexed for those with advanced NSCLC. It aims to see if these combinations are effective against these cancers.See study design
What are the potential side effects?
Possible side effects include immune system reactions leading to inflammation in various organs (like lungs or intestines), infusion-related reactions from the drugs being administered into a vein, fatigue from treatment burden on the body's energy resources, potential blood cell count changes affecting immunity and clotting.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer is confirmed by lab tests and cannot be removed by surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of study, approximately 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and duration of study, approximately 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Confirmed Objective Response Rate (ORR)
Secondary outcome measures
Disease control rate (DCR) per investigator assessment
Duration of response (DOR) per investigator assessment
Incidence of adverse events (AEs)
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: NSCLC ArmExperimental Treatment4 Interventions
SEA-CD40 + pembrolizumab + pemetrexed + carboplatin
Group II: Melanoma ArmExperimental Treatment2 Interventions
SEA-CD40 + pembrolizumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
pembrolizumab
2017
Completed Phase 3
~5750
pemetrexed
2005
Completed Phase 3
~5000
carboplatin
2010
Completed Phase 3
~4790

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,494 Total Patients Enrolled
Seagen Inc.Lead Sponsor
207 Previous Clinical Trials
69,080 Total Patients Enrolled
Jonathan Hayman, MDStudy DirectorSeagen Inc.
2 Previous Clinical Trials
907 Total Patients Enrolled

Media Library

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT04993677 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: NSCLC Arm, Melanoma Arm
Non-Small Cell Lung Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT04993677 — Phase 2
Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04993677 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many locations in the U.S. are actively engaged with this clinical investigation?

"This research is presently being conducted in 27 different medical centres. In the United States, these include Madison, Dallas and Quebec as well as many other sites that may be convenient to a potential participant's home."

Answered by AI

Are there any unfilled slots remaining in this trial?

"Right. The information hosted on clinicaltrials.gov displays that this medical trial is currently recruiting patients and was posted for the first time on October 6th 2021, with its most recent update occurring November 11th 2022. A total of 200 participants are required from 27 different sites to be involved in the study."

Answered by AI

How is SEA-CD40 typically employed to address medical conditions?

"SEA-CD40 is a viable medical intervention for malignant tumours, inoperable melanomas, and instances of high microsatellite instability."

Answered by AI

Has SEA-CD40 been investigated in any other scientific investigations?

"SEA-CD40 was initially assessed back in 2002 at H Central de Asturias. Since then, 1269 clinical trials have been concluded while 1596 are currently ongoing, a majority of which take place within Madison, Wisconsin."

Answered by AI

How many individuals are participating in the experiment?

"This clinical trial necessitates the participation of 200 qualified patients. Sites such as Carbone Cancer Center / University of Wisconsin in Madison, Wisconsin and University of Texas Southwestern/Simmons Cancer Center in Dallas, Texas are available for potential participants to join this study."

Answered by AI

Has the Food and Drug Administration sanctioned SEA-CD40 for therapeutic use?

"With prior evidence of SEA-CD40's safety, our team at Power assigned it a score of 2. Note that this evaluation is based on its status as a Phase 2 trial, suggesting limited efficacy data compared to the available safety research."

Answered by AI
~22 spots leftby Apr 2025