What side effects are associated with this type of intervention?

Treatments for esophageal cancer involving PD-1 and PD-L1 pathway inhibition, such as pembrolizumab and potentially SGN-PDL1V, commonly cause side effects like fatigue, rash, pruritus, diarrhea, and nausea. Severe immune-related adverse events can include pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis, due to the enhanced immune system activity leading to attacks on normal tissues.

What prior FDA approvals exist?

The FDA has approved pembrolizumab, a PD-1 inhibitor, for the treatment of esophageal cancer, particularly in patients with advanced/metastatic esophageal squamous cell carcinoma (SCC) or adenocarcinoma with high PD-L1 expression, as demonstrated in the KEYNOTE-181 trial. Avelumab, a PD-L1 inhibitor, was also evaluated in the JAVELIN Gastric 300 trial, but it did not show improved outcomes in esophageal cancer. These approvals highlight the role of PD-1 and PD-L1 pathway inhibitors in the treatment of esophageal cancer.

What other types of research exist?

Promising alternatives to SGN-PDL1V and Pembrolizumab for esophageal cancer patients include: 1) Nivolumab, another PD-1 inhibitor, which has shown efficacy in various cancers including esophageal cancer. 2) Atezolizumab, a PD-L1 inhibitor, which has been effective in other solid tumors and may offer benefits in esophageal cancer. 3) Combination therapies such as Nivolumab with Ipilimumab (CTLA-4 inhibitor) or Atezolizumab with chemotherapy, which have shown improved outcomes in other cancers and could be promising for esophageal cancer. 4) Trastuzumab deruxtecan, a HER2-targeted therapy, for HER2-positive esophageal cancer. These alternatives should be discussed with a healthcare provider to determine the best treatment plan.

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PD-L1 Inhibitor

SGN-PDL1V for Cancer

Phase 1

Recruiting

Research Sponsored by Seagen Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug, SGN-PDL1V, alone and with pembrolizumab, in patients with advanced solid tumors. The goal is to see if these treatments are safe and effective. SGN-PDL1V targets cancer cells directly, while pembrolizumab helps the immune system fight the cancer.

Who is the study for?

This trial is for adults with certain advanced solid tumors like lung, breast, esophageal cancer or melanoma that have spread and can't be surgically removed. Participants must have tried standard treatments without success or cannot tolerate them. They should be relatively active and well (ECOG score of 0 or 1) and not have had specific recent cancers, brain metastases, severe neuropathy, or treatment with similar drugs.

What is being tested?

SGN-PDL1V is being tested to determine its safety and effectiveness in treating various types of advanced solid tumors. The study has three parts: Parts A and B will decide the right dose; Part C will test this dose further for safety outcomes and how well it works against the cancer.

What are the potential side effects?

While the exact side effects are being studied, potential ones may include typical reactions to cancer therapy such as fatigue, nausea, inflammation-related symptoms due to immune response modulation by SGN-PDL1V, as well as any unexpected effects on organs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants with adverse events (AEs)

Secondary study objectives

Confirmed objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by investigator assessment

Duration of objective response (DOR) per RECIST v1.1 by investigator assessment

Incidence of anti-drug antibodies (ADAs)

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: PF-08046054 MonotherapyExperimental Treatment1 Intervention

PF-08046054 monotherapy

Group II: PF-08046054 Combination TherapyExperimental Treatment2 Interventions

PF-08046054 + pembrolizumab

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

pembrolizumab

2017

Completed Phase 3

~5890

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Esophageal cancer treatments often target the PD-1/PD-L1 pathways, which are crucial in the immune system's ability to recognize and attack cancer cells. PD-1 is a checkpoint protein on immune cells, and PD-L1 is its ligand found on cancer cells. When PD-L1 binds to PD-1, it inhibits the immune response, allowing cancer cells to evade detection. Drugs like pembrolizumab (PD-1 inhibitor) and investigational drugs like SGN-PDL1V (PD-L1 inhibitor) block this interaction, thereby enhancing the immune system's ability to target and destroy cancer cells. This mechanism is particularly important for esophageal cancer patients as it offers a targeted approach to boost the body's natural defenses against the tumor, potentially leading to better outcomes and fewer side effects compared to traditional chemotherapy.