Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
estimated completion
Principal Investigator
by Adil Daud (ucsf)
Headshot of Adil Daud
Adil Daud

Description

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.

Official Title

An Open-label, Phase 2 Basket Study of SEA-CD40 Combination Therapies in Advanced Malignancies

Keywords

Melanoma, Carcinoma, Non-Small- Cell Lung, Relapsed melanoma, Refractory melanoma, Metastatic uveal melanoma, Metastatic PD-(L)1-naïve melanoma, Non-squamous NSCLC, NSCLC, Non-small cell lung cancer, Seattle Genetics, Carcinoma, Non-Small-Cell Lung, Carboplatin, Pembrolizumab, Pemetrexed, SEA-CD40

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California at San Francisco accepting new patients
    San Francisco California 94134 United States
  • The Angeles Clinic and Research Institute accepting new patients
    Los Angeles California 90025 United States
  • California Pacific Medical Center Research Institute/Sutter Medical Centre accepting new patients
    San Francisco California 94115 United States

Lead Scientist at UC Cancer

  • Adil Daud (ucsf)
    Professor, Medicine, School of Medicine. Authored (or co-authored) 190 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Seagen Inc.
ID
NCT04993677
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 200 study participants
Last Updated