What side effects are associated with this type of intervention?

Immune checkpoint inhibitors, such as nivolumab, ipilimumab, and durvalumab, commonly cause immune-related side effects including skin reactions, endocrine events, pneumonitis, diarrhea, and pruritus. Serious adverse reactions can include pneumonia, febrile neutropenia, anemia, acute kidney injury, and respiratory failure. Fatal adverse reactions, though rare, have also been reported. These treatments can lead to significant immune-related adverse events that require careful monitoring and management.

What prior FDA approvals exist?

The FDA has approved several immune checkpoint inhibitors for cancer treatment. Notable examples include Pembrolizumab (Keytruda) and Nivolumab (Opdivo), which target the PD-1 receptor, and Atezolizumab (Tecentriq) and Avelumab (Bavencio), which target the PD-L1 ligand. These drugs have been approved for various cancers, including melanoma, non-small cell lung cancer, and urothelial carcinoma. Additionally, Ipilimumab (Yervoy), which targets CTLA-4, has been approved for melanoma. These treatments work by enhancing the immune system's ability to fight cancer.

What other types of research exist?

Promising novel alternatives to Livmoniplimab for cancer patients in 2024 include Pembrolizumab, Nivolumab, and Avelumab. These agents have demonstrated efficacy in various cancers, including melanoma, renal cell carcinoma, and mesothelioma, and are supported by recent clinical trial data.

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Monoclonal Antibodies

Livmoniplimab + Budigalimab for Cancer

Phase 1

Recruiting

Research Sponsored by AbbVie

Eligibility Criteria Checklist

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

Must have

Participants with histologically or cytologically confirmed advanced or metastatic NSCLC who have received 1 prior line of chemotherapy and 1 prior anti-PD-(L)1 antibody, administered either concurrently or sequentially in the metastatic setting.

HNSCC (arising from the oral cavity, oropharynx, hypopharynx, or larynx) and must have progressed following treatment with platinum-based regimen (administered in any line of therapy) and a PD1/PDL1 antagonist administered in the recurrent or metastatic setting (progression following a PD1/PDL1 antagonist is defined as unequivocal progression on or within 3 months of the last dose of anti-PD1 or anti-PDL1 therapy).

Must not have

Has a history of primary immunodeficiency, bone marrow transplantation, solid organ transplantation, or previous clinical diagnosis of tuberculosis.

Participants (except for participants with urothelial cancer or HNSCC) who have had prior exposure to immunotherapies as listed in the protocol.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 28 days after the first dose of livmoniplimab monotherapy

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing two experimental drugs, livmoniplimab and budigalimab, to see if they can help patients who need new treatment options by boosting their immune systems. Budigalimab is an experimental drug being tested for its effectiveness.

Who is the study for?

This trial is for adults with certain advanced solid tumors, including specific cancers of the bladder, urinary tract, pancreas, liver, and head/neck. Participants must have tried some treatments like platinum-based regimens or PD1/PDL1 antagonists without success. They should be in good physical condition (ECOG 0-1) and have proper organ function.

What is being tested?

The study tests Livmoniplimab alone and combined with Budigalimab to find a safe dose level and check their effects on cancer. It has two parts: first finding the right doses (dose escalation), then giving those doses to more people to learn more about safety and effectiveness (dose expansion).

What are the potential side effects?

Possible side effects include reactions at the infusion site, fatigue, nausea, immune-related conditions such as inflammation of organs or skin rashes. The severity can range from mild to serious but will be closely monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

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

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I have advanced NSCLC and have had one chemotherapy and one anti-PD-(L)1 treatment.

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My head or neck cancer worsened after platinum and PD1/PDL1 treatments.

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I am fully active or can carry out light work.

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My liver cancer has worsened despite one previous treatment.

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My colorectal cancer is stable and I've had 1-2 chemotherapy treatments.

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My bladder or urinary tract cancer worsened after platinum and PD1/PDL1 treatments.

Exclusion Criteria

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

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I have had a primary immunodeficiency, bone marrow or organ transplant, or tuberculosis.

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I have been treated with immunotherapies before, except if I have urothelial cancer or head and neck cancer.

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I have a history of specific severe reactions or lung, bowel, heart skin conditions.

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I have a health condition that is not under control.

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I have HCC, pancreatic cancer, or MSS-CRC and was treated with a PD-1/PD-L1 inhibitor before.

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I have side effects from cancer treatment that are not serious, except for hair loss.

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I have not received a live vaccine in the last 28 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 28 days after the first dose of livmoniplimab and budigalimab combination therapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 28 days after the first dose of livmoniplimab and budigalimab combination therapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 28 days after the first dose of livmoniplimab and budigalimab combination therapy 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: RP2D Livmoniplimab + Budigalimab Combination Therapy

Dose Escalation: Recommended Phase 2 Dose (RP2D) Livmoniplimab Monotherapy

Dose Expansion: Objective Response Rate (ORR)

Secondary study objectives

Area Under the Plasma Concentration-time Curve over time from 0 to last measurable concentration (AUCτ) of Budigalimab

Area Under the Plasma Concentration-time Curve over time from 0 to last measurable concentration (AUCτ) of Livmoniplimab

Change in Electrocardiogram (ECG)

+15 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

15Treatment groups

Experimental Treatment

Group I: Dose Expansion: Cohort 8 Livmoniplimab + BudigalimabExperimental Treatment2 Interventions

Participants with non-small cell lung cancer (NSCLC) \[programmed death ligand 1 (PDL1) relapsed/refractory (R/R)\] will receive livmoniplimab at the RP2D Q2W plus budigalimab Dose A administered Q4W.

Group II: Dose Expansion: Cohort 7 Livmoniplimab + BudigalimabExperimental Treatment2 Interventions

Participants with PD-1-naïve microsatellite stable colorectal cancer (MSS-CRC) \[unselected\] will receive livmoniplimab at the RP2D Q2W plus budigalimab Dose A administered Q4W.

Group III: Dose Expansion: Cohort 6 Livmoniplimab + BudigalimabExperimental Treatment2 Interventions

Participants with PD-1-ref head and neck squamous cell carcinoma (HNSCC) will receive livmoniplimab at the RP2D Q2W plus budigalimab Dose A administered Q4W.

Group IV: Dose Expansion: Cohort 5 Livmoniplimab + BudigalimabExperimental Treatment2 Interventions

Participants with PD-1-naïve hepatocellular carcinoma (HCC) will receive livmoniplimab at the RP2D Q2W plus budigalimab Dose A administered Q4W.

Group V: Dose Expansion: Cohort 4 Livmoniplimab + BudigalimabExperimental Treatment2 Interventions

Participants with PD-1-ref urothelial cancer will receive livmoniplimab at the RP2D Q2W plus budigalimab Dose A administered Q4W.

Group VI: Dose Expansion: Cohort 3 Livmoniplimab + BudigalimabExperimental Treatment2 Interventions

Participants with programmed cell death protein 1 (PD-1)-naïve pancreatic adenocarcinoma will receive livmoniplimab at the RP2D Q2W plus budigalimab Dose A administered Q4W.

Group VII: Dose Expansion: Cohort 12B Livmoniplimab + BudigalimabExperimental Treatment2 Interventions

Participants with PD-1-naïve ovarian granulosa (OG) cell tumors will receive livmoniplimab at the Dose C Q3W plus budigalimab Dose B administered Q3W.

Group VIII: Dose Expansion: Cohort 12A Livmoniplimab + BudigalimabExperimental Treatment2 Interventions

Participants with PD-1-naïve ovarian granulosa (OG) cell tumors will receive livmoniplimab at the Dose B Q3W plus budigalimab Dose B administered Q3W.

Group IX: Dose Expansion: Cohort 11C BudigalimabExperimental Treatment1 Intervention

Participants with PD-1-ref urothelial cancer will receive budigalimab Dose B administered Q3W.

Group X: Dose Expansion: Cohort 11B Livmoniplimab + BudigalimabExperimental Treatment2 Interventions

Participants with PD-1-ref urothelial cancer will receive livmoniplimab at the Dose C Q3W plus budigalimab Dose B administered Q3W.

Group XI: Dose Expansion: Cohort 11A Livmoniplimab + BudigalimabExperimental Treatment2 Interventions

Participants with PD-1-ref urothelial cancer will receive livmoniplimab at the Dose B Q3W plus budigalimab Dose B administered Q3W.

Group XII: Dose Expansion: Cohort 10B Livmoniplimab + BudigalimabExperimental Treatment2 Interventions

Participants with MSS-CRC (CMS4 enriched) will receive livmoniplimab at the dose C Q3W plus budigalimab Dose B administered Q3W.

Group XIII: Dose Expansion: Cohort 10A Livmoniplimab + BudigalimabExperimental Treatment2 Interventions

Participants with microsatellite stable colorectal cancer (MSS-CRC) \[consensus molecular subtype 4 (CMS4) enriched\] will receive livmoniplimab at the dose B Q3W plus budigalimab Dose B administered Q3W.

Group XIV: Dose Escalation: Cohort 2 Livmoniplimab + BudigalimabExperimental Treatment2 Interventions

Various doses of Livmoniplimab + Budigalimab administered during dose escalation to determine the Recommended Phase 2 Dose (RP2D).

Group XV: Dose Escalation: Cohort 1 LivmoniplimabExperimental Treatment1 Intervention

Various doses of Livmoniplimab administered during dose escalation to determine the Recommended Phase 2 Dose (RP2D).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Budigalimab

2021

Completed Phase 1

~170

0 / 13Eligibility 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 chemotherapy, targeted therapy, and immunotherapy. Chemotherapy uses drugs to kill rapidly dividing cells, but it can also affect healthy cells, leading to side effects. Targeted therapy focuses on specific molecules involved in cancer growth and spread, offering a more precise approach. Immunotherapy, particularly immune checkpoint inhibitors like Livmoniplimab, works by blocking proteins such as PD-1/PD-L1 and CTLA-4 that inhibit the immune system's ability to attack cancer cells. This mechanism is significant for cancer patients as it enhances the body's natural defenses to fight cancer, potentially leading to more effective and long-lasting treatment outcomes with fewer side effects.