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Hospital Clinico Universitario de Valencia | Nephrology Department

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

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Status and phase

Active, not recruiting
Phase 2

Conditions

Carcinoma, Non-Small- Cell Lung
Melanoma

Treatments

Drug: SEA-CD40
Drug: carboplatin
Drug: pemetrexed
Drug: pembrolizumab (KEYTRUDA®)

Study type

Interventional

Funder types

Industry

Identifiers

NCT04993677
KEYNOTE-C86 (Other Identifier)
SGNS40-002

Details and patient eligibility

About

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.

Enrollment

77 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

77 participants in 2 patient groups

Melanoma Arm
Experimental group
Description:
SEA-CD40 + pembrolizumab
Treatment:
Drug: SEA-CD40
Drug: pembrolizumab (KEYTRUDA®)
NSCLC Arm
Experimental group
Description:
SEA-CD40 + pembrolizumab + pemetrexed + carboplatin
Treatment:
Drug: SEA-CD40
Drug: pemetrexed
Drug: pembrolizumab (KEYTRUDA®)
Drug: carboplatin

Trial contacts and locations

29

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Data sourced from clinicaltrials.gov

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