A Study of SEA-CD40 Given With Other Drugs in Cancers
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| ClinicalTrials.gov Identifier: NCT04993677 |
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Recruitment Status :
Active, not recruiting
First Posted : August 6, 2021
Last Update Posted : March 10, 2023
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Sponsor:
Seagen Inc.
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Seagen Inc.
- Study Details
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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 |
|---|---|---|
| Melanoma Carcinoma, Non-Small- Cell Lung | Drug: SEA-CD40 Drug: pembrolizumab Drug: pemetrexed Drug: carboplatin | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 77 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 : | October 6, 2021 |
| Estimated Primary Completion Date : | October 31, 2024 |
| Estimated Study Completion Date : | October 31, 2025 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Melanoma
MedlinePlus related topics:
Melanoma
| Arm | Intervention/treatment |
|---|---|
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Experimental: Melanoma Arm
SEA-CD40 + pembrolizumab
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Drug: SEA-CD40
Given into the vein (IV; intravenously); schedule is cohort-specific Drug: pembrolizumab Given by IV; schedule is cohort-specific.
Other Name: Keytruda |
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Experimental: NSCLC Arm
SEA-CD40 + pembrolizumab + pemetrexed + carboplatin
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Drug: SEA-CD40
Given into the vein (IV; intravenously); schedule is cohort-specific Drug: pembrolizumab Given by IV; schedule is cohort-specific.
Other Name: Keytruda Drug: pemetrexed Given by IV on Day 1 of each 21-day cycle.
Other Name: Alimta Drug: carboplatin Given by IV on Day 1 of Cycles 1-4. Each cycle will be 21 days long.
Other Name: Paraplatin |
Primary Outcome Measures :
- Confirmed Objective Response Rate (ORR) [ Time Frame: 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 :
- Incidence of adverse events (AEs) [ Time Frame: 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.
- Incidence of laboratory abnormalities [ Time Frame: From start of treatment to 30-37 days after last dose, approximately 2 years ]To be summarized using descriptive statistics
- Incidence of dose alterations [ Time Frame: Duration of treatment, approximately 2 years ]To be summarized using descriptive statistics
- Disease control rate (DCR) per investigator assessment [ Time Frame: 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.
- Duration of response (DOR) per investigator assessment [ Time Frame: 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
- Progression-free survival (PFS) per investigator assessment [ Time Frame: 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
- Overall survival (OS) [ Time Frame: Duration of study, approximately 4 years ]The time from the start of study treatment to date of death due to any cause
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
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Histologically or cytologically confirmed unresectable malignancy defined as one of the following:
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Cohort 1: Relapsed and/or refractory metastatic melanoma
- Uveal/ocular melanoma is excluded
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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
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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
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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.
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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
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- 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04993677
Locations
Show 29 study locations
Sponsors and Collaborators
Seagen Inc.
Merck Sharp & Dohme LLC
Investigators
| Study Director: | Jonathan Hayman, MD | Seagen Inc. |
| Responsible Party: | Seagen Inc. |
| ClinicalTrials.gov Identifier: | NCT04993677 |
| Other Study ID Numbers: |
SGNS40-002 KEYNOTE-C86 ( Other Identifier: Merck Sharp & Dohme Corp ) |
| First Posted: | August 6, 2021 Key Record Dates |
| Last Update Posted: | March 10, 2023 |
| Last Verified: | March 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| 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.:
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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:
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Melanoma Carcinoma, Non-Small-Cell Lung Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Carcinoma, Bronchogenic Bronchial Neoplasms Lung Neoplasms Respiratory Tract Neoplasms |
Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases Carboplatin Pembrolizumab Pemetrexed Antineoplastic Agents Antineoplastic Agents, Immunological Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |