BA3071 + Nivolumab for Cancer

Recruiting in Palo Alto (17 mi)

+13 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: BioAtla, Inc.

Disqualifiers: Cardiac disease, CNS metastasis, HIV, others

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The objective of this study is to assess safety and efficacy of BA3071 in solid tumors

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug combination BA3071 + Nivolumab for cancer?

Research shows that Nivolumab, a part of this drug combination, has been effective in improving survival in patients with advanced melanoma and has shown activity in treating advanced lung cancer. This suggests potential benefits when used in combination with other treatments like BA3071. ^{1 2 3 4 5}

What safety information is available for Nivolumab in cancer treatment?

Nivolumab, used in cancer treatment, can cause immune-related side effects, including issues with the thyroid and other endocrine (hormone-related) problems. These side effects may limit the safety and continuation of therapy. ^{5 6 7 8 9}

What makes the drug BA3071 + Nivolumab unique for cancer treatment?

BA3071 + Nivolumab is unique because it combines a novel treatment, BA3071 (Evalstotug), with Nivolumab, an established immune checkpoint inhibitor that blocks PD-1 to enhance the body's immune response against cancer. This combination may offer a new approach by potentially improving the effectiveness of Nivolumab, which has already shown benefits in various cancers. ^{1 5 7 10 11}

Research Team

Eligibility Criteria

This trial is for adults (18+) with various advanced solid tumors who haven't been treated with CLTA-4 blocking antibodies. They must be in good physical condition, have normal blood, liver, and kidney functions, and measurable disease. Pregnant or breastfeeding women, those with recent major surgery, significant heart issues, uncontrolled brain metastases or severe allergies to monoclonal antibodies can't participate.

Inclusion Criteria

I am fully active or can carry out light work.

I have never received CTLA-4 blocking-antibody treatment.

My blood counts are within normal ranges.

Exclusion Criteria

I do not have uncontrolled brain metastases.

I do not have any serious heart conditions.

I have not had major surgery in the last 4 weeks.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BA3071 in combination with PD-1 inhibitor and chemotherapy to evaluate safety, tolerability, PK, immunogenicity, and antitumor activity

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

Treatment Details

Interventions

• BA3071 (Unknown)
• Nivolumab (Checkpoint Inhibitor)

Trial Overview The study tests the safety and effectiveness of BA3071 alone and combined with PD-1 blockers Pembrolizumab or Nivolumab in treating solid tumors. It aims to find out how well these treatments work against different types of cancer.

Participant Groups

Group I: Neoadjuvant Combination Therapy + Chemotherapy Experimental Treatment 3 Interventions

Conditionally active biologic (CAB) antibody that binds to CTLA-4 with PD-1 inhibitor + Chemotherapy prior to surgical resection

Group II: Combination Therapy + Chemotherapy Experimental Treatment 3 Interventions

Conditionally active biologic (CAB) antibody that binds to CTLA-4 with PD-1 inhibitor + Chemotherapy

Group III: Combination Therapy Experimental Treatment 3 Interventions

Conditionally active biologic (CAB) antibody that binds to CTLA-4 with PD-1 inhibitor

Group IV: BA3071 Experimental Treatment 1 Intervention

Conditionally active biologic (CAB) antibody that binds to CTLA-4

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Gabrail Cancer Center Research Canton, OH

Morristown Medical Center/Atlantic Health System Morristown, NJ

Northwest Cancer Centers Dyer, IN

Icahn School of Medicine at Mt. Sinai New York, NY

More Trial Locations

Who Is Running the Clinical Trial?

BioAtla, Inc.

Lead Sponsor

Trials

7

Patients Recruited

1,500+

References

1. England pubmed.ncbi.nlm.nih.gov

Activity and safety of nivolumab, an anti-PD-1 immune checkpoint inhibitor, for patients with advanced, refractory squamous non-small-cell lung cancer (CheckMate 063): a phase 2, single-arm trial. [2022] Patients with squamous non-small-cell lung cancer that is refractory to multiple treatments have poor outcomes. We assessed the activity of nivolumab, a fully human IgG4 PD-1 immune checkpoint inhibitor antibody, for patients with advanced, refractory, squamous non-small-cell lung cancer.

2. Spain pubmed.ncbi.nlm.nih.gov

Effectiveness and safety of atezolizumab, nivolumab and pembrolizumab in metastatic non-small cell lung cancer. [2021] To determine the effectiveness and safety of atezolizumab, nivolumab and pembrolizumab in patients with non-small cell lung cancer.

3. Switzerland pubmed.ncbi.nlm.nih.gov

Treatment Beyond Progression in Patients with Advanced Renal Cell Carcinoma Treated with Nivolumab in CheckMate 025. [2022] Response patterns to nivolumab differ from those seen with other approved targeted therapies.

4. England pubmed.ncbi.nlm.nih.gov

Soluble CD73 as biomarker in patients with metastatic melanoma patients treated with nivolumab. [2018] Nivolumab is an anti-PD1 checkpoint inhibitor active in patients with advanced melanoma and as adjuvant therapy in high-risk metastatic melanoma patients.

5. Germany pubmed.ncbi.nlm.nih.gov

The cost-effectiveness of nivolumab monotherapy for the treatment of advanced melanoma patients in England. [2020] Nivolumab was the first programmed death receptor 1 (PD-1) immune checkpoint inhibitor to demonstrate long-term survival benefit in a clinical trial setting for advanced melanoma patients.

6. United States pubmed.ncbi.nlm.nih.gov

Do endocrine adverse events predict longer progression-free survival among patients with non-small-cell lung cancer receiving nivolumab? [2021] The aim of the study was to assess the occurrence and nature of immune-related endocrine adverse events (irAEs) among patients with non-small-cell lung cancer (NSCLC) treated with nivolumab.

7. Spain pubmed.ncbi.nlm.nih.gov

Nivolumab-induced thyroid dysfunction in patients with lung cancer. [2021] Nivolumab is an anti-cancer monoclonal antibody that inhibits PD1 and modulates T-cell response. It has been shown to significantly improve survival in several types of cancer, but clinical trials have also reported an increased risk of developing immune-related adverse events (IRAEs). Endocrine IRAEs may be particularly relevant.

8. England pubmed.ncbi.nlm.nih.gov

An update on the safety of nivolumab for the treatment of advanced melanoma. [2021] Introduction: Due to its unique mechanism of action as an immune checkpoint inhibitor, nivolumab has high antitumor activity, but at the same time this mechanism is responsible for immune-related adverse events that may limit patients' safety and therapy continuation.Areas covered: Long-term safety of nivolumab including 5-year follow-up, safety of nivolumab treatment after ipilimumab therapy, safety of nivolumab in challenging subgroups (elderly, patients with brain metastases, patients with autoimmune disorders), safety of nivolumab in with rare melanoma subtypes (including mucosal melanoma), as well as specificity of AEs reported for nivolumab treatment in melanoma patients in comparison to other cancer types and other immunotherapy molecules, and impact of AEs on response rates and PFS on nivolumab treatment are discussed.Expert opinion: Search for biomarkers that would help us to identify patient populations that may suffer from severe nivolumab toxicity could help in selecting patients that should not be treated with this type of therapy. Novel combinations and immunotherapy drugs including use of NKTR-214 (IL-2 pathway), lymphocyte-activation gene 3 (LAG-3), local injections of talimogene laherparepvec (T-VEC), or systemic use of T-cell receptors agonists such as OX40, CD137, ICOS-1, could provide regimens with limited toxicity and higher activity.

9. United States pubmed.ncbi.nlm.nih.gov

Safety of First-Line Nivolumab Plus Ipilimumab in Patients With Metastatic NSCLC: A Pooled Analysis of CheckMate 227, CheckMate 568, and CheckMate 817. [2023] We characterized the safety of first-line nivolumab plus ipilimumab (NIVO+IPI) in a large patient population with metastatic NSCLC and efficacy outcomes after NIVO+IPI discontinuation owing to treatment-related adverse events (TRAEs).

10. England pubmed.ncbi.nlm.nih.gov

Nivolumab serum concentration in metastatic melanoma patients could be related to outcome and enhanced immune activity: a gene profiling retrospective analysis. [2023] Nivolumab is an anti-PD-1 antibody approved for treating metastatic melanoma (MM), for which still limited evidence is available on the correlation between drug exposure and patient outcomes.

11. Greece pubmed.ncbi.nlm.nih.gov

Analysis of Pleiotropic Effects of Nivolumab in Pretreated Advanced or Recurrent Non-small Cell Lung Cancer Cases. [2020] Nivolumab is an immune checkpoint inhibitor for advanced non-small cell lung cancer (NSCLC). We investigated the safety and efficacy of nivolumab by analyzing the response factor, adverse effects (AE), and the post-treatment condition of pretreated advanced or recurrent NSCLC patients.