BA3071 + Nivolumab for Cancer
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: BioAtla, Inc.
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
Do I have to stop taking my current medications?The trial protocol does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more information.
Is the drug BA3071 (Evalstotug) combined with Nivolumab a promising treatment for cancer?Nivolumab, when used in combination with other treatments, has shown to improve survival in various cancers, including lung cancer and melanoma. It works by helping the immune system fight cancer more effectively. This suggests that combining Nivolumab with BA3071 (Evalstotug) could be promising for treating cancer.145611
What safety data is available for BA3071 + Nivolumab in cancer treatment?The safety data for Nivolumab, which is part of the BA3071 + Nivolumab treatment, indicates that it can cause immune-related adverse events (IRAEs), particularly endocrine-related ones. Studies have shown that Nivolumab can lead to thyroid dysfunction and other endocrine adverse events in cancer patients. Additionally, pooled analyses of clinical trials like CheckMate 227, 568, and 817 have characterized the safety of Nivolumab, especially when used in combination with other drugs like Ipilimumab. Long-term safety data for Nivolumab in melanoma patients highlight the potential for severe toxicities, suggesting the need for careful patient selection and monitoring.457910
What data supports the idea that BA3071 + Nivolumab for Cancer is an effective treatment?The available research shows that Nivolumab, which is part of the BA3071 + Nivolumab treatment, has been effective in treating certain types of cancer. For example, it has shown long-term survival benefits for patients with advanced melanoma, a type of skin cancer. Additionally, Nivolumab has been used successfully in patients with advanced squamous non-small-cell lung cancer, even when other treatments have failed. These studies suggest that Nivolumab can be a powerful option for treating these cancers, which supports the idea that BA3071 + Nivolumab could be effective as well.12348
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.
I am 18 years old or older.
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.
I am not pregnant or breastfeeding.
I do not have HIV, active hepatitis B, or hepatitis C.
Treatment Details
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.
4Treatment groups
Experimental Treatment
Group I: Neoadjuvant Combination Therapy + ChemotherapyExperimental Treatment3 Interventions
Conditionally active biologic (CAB) antibody that binds to CTLA-4 with PD-1 inhibitor + Chemotherapy prior to surgical resection
Group II: Combination Therapy + ChemotherapyExperimental Treatment3 Interventions
Conditionally active biologic (CAB) antibody that binds to CTLA-4 with PD-1 inhibitor + Chemotherapy
Group III: Combination TherapyExperimental Treatment3 Interventions
Conditionally active biologic (CAB) antibody that binds to CTLA-4 with PD-1 inhibitor
Group IV: BA3071Experimental Treatment1 Intervention
Conditionally active biologic (CAB) antibody that binds to CTLA-4
Find a clinic near you
Research locations nearbySelect from list below to view details:
Gabrail Cancer Center ResearchCanton, OH
Morristown Medical Center/Atlantic Health SystemMorristown, NJ
Northwest Cancer CentersDyer, IN
Icahn School of Medicine at Mt. SinaiNew York, NY
More Trial Locations
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Who is running the clinical trial?
BioAtla, Inc.Lead Sponsor
References
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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.