What side effects are associated with this type of intervention?

Pembrolizumab, a PD-1 inhibitor, commonly causes immune-related side effects such as pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis. Chemotherapy agents, often used in combination, can lead to nausea, vomiting, fatigue, hair loss, and myelosuppression. Severe side effects may include infections, neuropathy, and organ toxicity. Combining these treatments can heighten the risk of severe immune-related and systemic toxicities.

What prior FDA approvals exist?

Pembrolizumab, a PD-1 inhibitor, has been approved by the FDA for various solid tumors, including non-small cell lung cancer (NSCLC), melanoma, and Merkel cell carcinoma. It has been studied in combination with chemotherapy agents like pemetrexed and platinum (KEYNOTE-189), and with other immunotherapies such as nivolumab and ipilimumab. Other PD-1 inhibitors like nivolumab have also received FDA approval for similar indications. Additionally, combinations involving PD-L1 inhibitors like atezolizumab with chemotherapy have been approved for NSCLC. These approvals highlight the efficacy of immune checkpoint inhibitors, either as monotherapy or in combination with other treatments, in managing advanced solid tumors.

What other types of research exist?

Promising alternatives to BDB018 in combination with Pembrolizumab for solid tumors include: 1. Durvalumab (PD-L1 inhibitor) combined with Tremelimumab (CTLA-4 inhibitor), which has shown trends towards improved overall survival in certain patient groups. 2. Atezolizumab (PD-L1 inhibitor) combined with chemotherapy, which has demonstrated efficacy in various solid tumors. 3. Nivolumab (PD-1 inhibitor) combined with Ipilimumab (CTLA-4 inhibitor), which has shown higher response rates in patients with high tumor mutational burden. These combinations are supported by recent clinical trials and studies, making them viable options for treatment in 2024.

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BDB018 + Pembrolizumab for Advanced Cancer

Phase 1

Waitlist Available

Research Sponsored by Seven and Eight Biopharmaceuticals Inc

Eligibility Criteria Checklist

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

Must have

Histologically or cytologically confirmed advanced or metastatic solid tumors that have disease progression after treatment with all available therapies for metastatic disease that are known to confer clinical benefit, or are intolerant to treatment, or refuse standard treatment. Note: there is no limit to the number of prior treatment regimens

Be older than 18 years old

Must not have

Has disease that is suitable for local therapy administered with curative intent.

Prior exposure to TLR7 agonists, TLR8 agonists, TLR 7/8 dual agonists, and TLR9 agonists.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 months

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is testing a new drug called BDB018, both by itself and with another drug called pembrolizumab. It aims to help patients with advanced cancers that don't respond to other treatments. BDB018 works by boosting the immune system to better attack cancer cells. Pembrolizumab is a humanized antibody approved for the treatment of various types of cancer.

Who is the study for?

This trial is for adults with advanced solid tumors that have worsened within the last 3 months despite treatment, or who can't tolerate or refuse standard treatments. They must have measurable disease and not have been treated with TLR7, TLR8, dual agonists, or TLR9 agonists before.

What is being tested?

The study is testing BDB018 on its own and combined with Pembrolizumab in patients. It's a Phase 1 trial to find out the right dose of BDB018 and see how safe it is when given alone or with Pembrolizumab to people with advanced solid tumors.

What are the potential side effects?

Possible side effects include reactions at the injection site, flu-like symptoms such as fever and chills, fatigue, changes in blood tests affecting organs like liver and kidneys. Side effects may vary between monotherapy and combination therapy.

Eligibility Criteria

Inclusion Criteria

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

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My advanced cancer has worsened after all treatments, or I can't tolerate/refuse standard treatments.

Exclusion Criteria

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

Select...

My condition can be treated with the goal of curing it.

Select...

I have been treated with TLR7, TLR8, or TLR9 drugs before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Safety and Tolerability: incidence of adverse events and any dose limiting toxicity

Secondary study objectives

Determine Maximum Tolerated Dose

Radiographic Determination of Tumor Response after BDB018 Dosing

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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: BDB018 in MonotherapyExperimental Treatment1 Intervention

A single subject will be enrolled at each dose level in the single agent arm. Then dosage escalation will follow a traditional 3+3 dose escalation design. Each successive group of patients will be enrolled at an incrementally higher dosage until the Maximum Tolerable Dose (MTD) or Recommended Phase 2 Dose (RP2D) of single agent BDB018 is reached.

Group II: BDB018 in Combination with PembrolizumabExperimental Treatment2 Interventions

In the combination arm of the study, a standard 3+3 dose escalation design will be utilized for all dose levels. When the MTD or RP2D of single agent BDB018 is reached, the first dose level cohort of the combination arm will begin. Once the MTD or RP2D in combination has been determined, approximately twenty additional subjects will be enrolled in the expansion phase of the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

FDA approved

0 / 3Eligibility 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

The most common treatments for solid tumors include immune checkpoint inhibitors such as Pembrolizumab, which is a PD-1 inhibitor. These treatments work by blocking the PD-1 pathway, a mechanism that tumors use to evade the immune system. By inhibiting this pathway, Pembrolizumab allows the immune system to recognize and attack cancer cells more effectively. Understanding these mechanisms is crucial for patients with solid tumors because it highlights the importance of the immune system in fighting cancer and helps in anticipating potential side effects and the overall effectiveness of the treatment.

Paradigms on Immunotherapy Combinations with Chemotherapy.Recurrent glioma clinical trial, CheckMate-143: the game is not over yet.Nivolumab Immunotherapy in Malignant Mesothelioma: A Case Report Highlighting a New Opportunity for Exceptional Outcomes.