What side effects are associated with this type of intervention?

Treatments for solid tumors, particularly immune checkpoint inhibitors like pembrolizumab, commonly cause side effects such as fatigue, rash, diarrhea, and immune-related adverse events including pneumonitis, colitis, hepatitis, and endocrinopathies. Targeted therapies may lead to skin reactions, hypertension, and gastrointestinal issues. Severe side effects often necessitate management with steroids or other immunosuppressive agents.

What prior FDA approvals exist?

The FDA has approved several immune checkpoint inhibitors and targeted therapies for the treatment of solid tumors. Pembrolizumab (Keytruda) and nivolumab (Opdivo) are notable immune checkpoint inhibitors that target PD-1 and have been approved for various cancers, including melanoma, non-small cell lung cancer, and renal cell carcinoma. Ipilimumab (Yervoy), which targets CTLA-4, is also approved for melanoma. Additionally, combination therapies such as nivolumab with ipilimumab have shown efficacy in treating advanced melanoma and renal cell carcinoma. These treatments work by modulating the immune system to target and destroy cancer cells, similar to the investigational approach of BNT314.

What other types of research exist?

Promising novel alternatives to BNT314 for solid tumor patients in 2024 include: <ol> <li>Pembrolizumab combined with other agents such as bevacizumab or axitinib, which have shown efficacy in various solid tumors.</li> <li></li> </ol> Nivolumab and ipilimumab combination therapy, particularly for melanoma and renal cell carcinoma. 3. Relatlimab combined with nivolumab, which has shown promise in untreated advanced melanoma. 4. Cabozantinib combined with atezolizumab, which has demonstrated positive results in advanced renal cell carcinoma. 5. Venetoclax combined with BTK inhibitors like ibrutinib or acalabrutinib, which are being investigated for their potential in various cancers.

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BNT314 +/- Immune Checkpoint Inhibitor for Cancer

Phase 1 & 2

Recruiting

Research Sponsored by BioNTech SE

Eligibility Criteria Checklist

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

Must have

Have adequate pancreas function at screening

Males who are sexually active and have not had a bilateral vasectomy or orchidectomy must agree to use condoms with a spermicidal agent and to require their female partners to practice a highly effective form of contraception during the study

Must not have

Patients that have uncontrolled intercurrent illness

Uncontrolled hypertension defined as systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥100 mm Hg, despite optimal medical management

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years after first dose of study treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the safety and effectiveness of a new drug, BNT314, alone and with pembrolizumab, in patients with advanced cancers who lack other treatment options. BNT314 aims to attack cancer cells directly, while pembrolizumab boosts the immune system's ability to fight cancer. Pembrolizumab has been shown to improve recurrence-free survival in various cancers and is approved for multiple indications.

Who is the study for?

Adults over 18 with advanced solid tumors that have worsened after standard treatment or who can't tolerate such treatments. They must be able to consent, follow study procedures, and have a life expectancy of more than 3 months. Good physical condition (ECOG score of 0 or 1) and proper organ function are required. Women must test negative for pregnancy and agree to contraception; men also need to use contraception.

What is being tested?

The trial is testing BNT314's safety alone and combined with pembrolizumab in cancer patients. It has three parts: dose escalation to find the safest high dose, a safety run-in combining both drugs in a small group, followed by an expansion phase treating up to 199 patients with this combination.

What are the potential side effects?

Potential side effects include typical reactions from immune therapies like inflammation in various organs, infusion-related symptoms, fatigue, digestive issues, blood disorders, increased risk of infections among others.

Eligibility Criteria

Inclusion Criteria

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

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My pancreas is working well.

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I am a man who can father children and will use condoms and ensure my partner uses contraception during the study.

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My cancer has worsened after standard treatment, or I couldn't tolerate or wasn't eligible for it.

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I am 18 years old or older.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

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

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I do not have any unmanaged ongoing illnesses.

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My blood pressure is very high despite taking medication.

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I have been diagnosed with interstitial lung disease.

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I have had lung inflammation treated with steroids.

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I do not have any serious, non-healing wounds, skin ulcers, or bone fractures.

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I have not used any experimental drugs or devices within the last 28 days.

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I have been on steroids or other immune-weakening drugs in the last 2 weeks.

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I have an autoimmune disease treated with immunosuppressants in the last year.

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I have a history of chronic liver disease or cirrhosis.

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I do not have untreated brain or spinal cord conditions.

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I have had cancer spread to my brain or central nervous system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years after first dose of study treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years after first dose of study treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years after first dose of study treatment for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Combination therapy - Expansion. Objective response rate (ORR) based on investigator's tumor assessment according to RECIST 1.1

Secondary study objectives

Combination therapy - Expansion. DCR based on investigator's tumor assessment according to RECIST 1.1

Combination therapy - Expansion. DOR based on investigator's tumor assessment according to RECIST 1.1

Combination therapy - Expansion. OS

+9 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: BNT314 MonotherapyExperimental Treatment1 Intervention

Escalating dose levels and backfill cohorts

Group II: BNT314 + pembrolizumabExperimental Treatment2 Interventions

The BNT314 starting dose for the SRI combination therapy will be one DL lower than the RP2D/MTD/maximum administered dose (MAD) determined from the monotherapy dose escalation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3130

0 / 16Eligibility 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 treatments for solid tumors often involve immune modulation and targeted therapies. Immune modulation, using drugs like pembrolizumab, enhances the body's immune response to attack cancer cells more effectively. Targeted therapies, such as monoclonal antibodies, specifically target cancer cell markers to inhibit their growth and survival. These approaches are significant for solid tumor patients as they provide more precise treatment options with potentially fewer side effects compared to traditional chemotherapy, improving overall outcomes and quality of life.