What side effects are associated with this type of intervention?

Common side effects of cancer treatments that modulate the immune response or have direct anti-cancer effects, such as immune checkpoint inhibitors (e.g., nivolumab, ipilimumab), include skin reactions, endocrine events, and gastrointestinal issues like diarrhea. Severe adverse events can include pneumonia, febrile neutropenia, and pneumonitis. Infusion reactions are also notable, especially with agents like rituximab. These treatments can lead to serious complications such as hepatic toxicity, acute renal failure, and sepsis, and may require discontinuation in some cases.

What prior FDA approvals exist?

The FDA has approved several drugs that modulate the immune response or have direct anti-cancer effects. For instance, pembrolizumab and nivolumab are immune checkpoint inhibitors that target PD-1, enhancing the body's immune response against cancer cells. Ipilimumab, another immune checkpoint inhibitor, targets CTLA-4 and is approved for melanoma. Additionally, combination therapies like nivolumab plus ipilimumab have shown efficacy in various cancers, including renal cell carcinoma. Vemurafenib and dabrafenib are BRAF inhibitors approved for BRAF V600 mutation-positive melanoma, directly targeting cancer cell growth. These treatments highlight the FDA's focus on both immune modulation and direct anti-cancer strategies.

What other types of research exist?

Promising novel alternatives to VVD-130850 for cancer patients include: 1) TriMixDC-MEL, an mRNA electroporated autologous monocyte-derived dendritic cell therapy, which has shown potential in improving disease-free survival in melanoma patients. 2) Adjuvant nivolumab and pembrolizumab, both of which are immune checkpoint inhibitors that have demonstrated improved recurrence-free survival in high-risk melanoma patients. 3) T-VEC (Talimogene laherparepvec), an oncolytic virus therapy that has shown favorable and durable responses in advanced melanoma. 4) Combination therapies such as nivolumab plus ipilimumab, which have shown potential for durable long-term responses in renal cell carcinoma. These therapies represent significant advancements in cancer treatment and may offer effective alternatives to VVD-130850.

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VVD-130850 for Advanced Cancer

Phase 1

Recruiting

Research Sponsored by Vividion Therapeutics, Inc.

Eligibility Criteria Checklist

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

Must have

Histologically or cytologically confirmed metastatic or unresectable solid tumor or advanced non-Hodgkin's lymphoma (NHL)

Eastern Cooperative Oncology Group (ECOG) performance status ≤1

Must not have

Prior allogeneic transplantation

Combination Therapy Expansion: Known hypersensitivity or contraindication to pembrolizumab or any of its components

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called VVD-130850 to see if it is safe and how it behaves in the body. The study focuses on patients with advanced solid and blood-related cancers. Researchers want to know if the drug can help fight cancer on its own and if it can make other immune-based treatments more effective.

Who is the study for?

This trial is for individuals with advanced solid tumors or blood cancers who have not responded to standard treatments. Participants must be adults, able to give consent, and meet specific health criteria.

What is being tested?

The study tests VVD-130850 alone and combined with Pembrolizumab (a checkpoint inhibitor) to assess safety, how the body processes it, and its effects on cancer cells in patients with advanced tumors.

What are the potential side effects?

Potential side effects may include typical reactions seen with cancer therapies such as fatigue, nausea, immune-related issues due to Pembrolizumab's action on the immune system, and other drug-specific adverse events.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is advanced and cannot be removed by surgery.

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I am fully active or can carry out light work.

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My NSCLC has a specific mutation (STK11/LKB1).

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a transplant from another person.

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I am allergic to pembrolizumab or its ingredients.

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I have an immune system disorder or am on medication that weakens my immune system.

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I do not have any serious infections, including eye infections.

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I have a history of heart disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 4 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

Dose Escalation: Incidence and Severity of Dose-limiting Toxicities (DLTs) During DLT Observation Period

Secondary study objectives

Dose Escalation: QT/Corrected QT (QTc) Interval and Other Electrocardiogram (ECG) Parameters

Dose Escalation: Recommended Dose for Expansion (RDE) of VVD-130850 as a Single Agent and in Combination with Pembrolizumab

Dose Expansion: Disease Control Rate (DCR)

+3 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Group I: Dose Expansion: VVD-130850 Single AgentExperimental Treatment1 Intervention

Participants will receive VVD-130850 at recommended dose for expansion (RDE), orally, once daily in 21-day treatment cycles during the dose expansion phase.

Group II: Dose Expansion: VVD-130850 + Pembrolizumab Combination TherapyExperimental Treatment2 Interventions

Participants will receive VVD-130850 at RDE orally, once daily along with pembrolizumab IV infusion, Q3W in 21-day treatment cycles during the dose expansion phase.

Group III: Dose Escalation: VVD-130850 Single AgentExperimental Treatment1 Intervention

Participants will receive ascending doses of VVD-130850, orally, once daily in 21-day treatment cycles during the dose escalation phase.

Group IV: Dose Escalation: VVD-130850 + Pembrolizumab Combination TherapyExperimental Treatment2 Interventions

Participants will receive ascending doses of VVD-130850, orally, once daily, along with pembrolizumab intravenous (IV) infusion, every 3 weeks (Q3W) in 21-day treatment cycles during the dose escalation phase.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3150

0 / 8Eligibility criteria met

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

Common cancer treatments include immune checkpoint inhibitors, targeted therapies, chemotherapy, and radiation. Immune checkpoint inhibitors, such as PD-1/PD-L1 and CTLA-4 inhibitors, work by enhancing the body's immune response against cancer cells, allowing T-cells to recognize and attack tumors more effectively. Targeted therapies focus on specific molecular targets associated with cancer, such as mutated proteins or signaling pathways, to inhibit tumor growth and survival. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cancer cells, while radiation therapy uses high-energy particles to damage the DNA of cancer cells, leading to cell death. These treatments are crucial for cancer patients as they offer multiple strategies to combat the disease, potentially improving survival rates and quality of life.

Expanding Therapeutic Options for Older Adults: Case-Based Updates in Breast and Lung Cancer.