BI-1206 + Pembrolizumab for Advanced Cancer

Recruiting in Palo Alto (17 mi)

+6 other locations

Overseen by Carneiro, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: BioInvent International AB

Must be taking: Anti-PD-1/PD-L1 therapy

Must not be taking: Corticosteroids, Immunotherapy

Disqualifiers: CNS metastases, Autoimmune disease, others

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial tests BI-1206 and pembrolizumab in patients with advanced solid tumors who didn't respond well to previous treatments. BI-1206 removes a shield protecting cancer cells, and pembrolizumab boosts the body's natural defenses to fight the cancer.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have had chemotherapy, small molecule products, or immunotherapy within 4 weeks of starting the trial. Additionally, you cannot take more than 10 mg of prednisolone daily or similar corticosteroids.

What data supports the effectiveness of the drug pembrolizumab in treating advanced cancer?

Pembrolizumab has shown effectiveness in treating various cancers, including non-small cell lung cancer and advanced melanoma, by improving survival rates and tumor response. It works by helping the immune system attack cancer cells more effectively. ^{1 2 3 4 5}

Is the combination of BI-1206 and Pembrolizumab safe for humans?

Pembrolizumab, also known as Keytruda, has been used in various cancer treatments and is generally considered safe, but it can cause side effects like fatigue, nausea, and immune-related issues such as thyroid problems and, rarely, type 1 diabetes. While specific safety data for the combination with BI-1206 is not provided, pembrolizumab's safety profile is well-documented in other conditions. ^{1 2 4 6 7}

What makes the drug BI-1206 + Pembrolizumab unique for advanced cancer?

The combination of BI-1206 and Pembrolizumab is unique because it pairs a novel treatment (BI-1206) with Pembrolizumab, a PD-1 inhibitor that helps the immune system attack cancer cells. This combination may offer a new approach for treating advanced cancers by potentially enhancing the immune response against tumors. ^{1 2 8 9 10}

Research Team

Carneiro, PhD

Principal Investigator

Lund University Hospital

Eligibility Criteria

Adults with advanced solid tumors who've had at least two doses of anti-PD-1/L1 therapy and disease progression within 12 weeks after the last dose. They must have measurable disease, a life expectancy over 12 weeks, good organ function, and be able to consent. Exclusions include active brain metastases, severe pneumonitis history, high steroid needs, pregnancy or breastfeeding women, recent major surgery recovery patients, high medical risk due to systemic diseases including infections or graft versus host disease.

Inclusion Criteria

I have metastatic melanoma and have been treated with anti-PD-1 therapy, and if applicable, BRAF-targeted therapy.

Is willing and able to provide written informed consent for the trial.

I can safely have a biopsy before starting BI-1206 treatment.

Exclusion Criteria

Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.

I need more than 10 mg of prednisolone or a similar medication daily.

I have AL amyloidosis affecting my heart or kidneys.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Treatment

Dose-finding with BI-1206 in combination with pembrolizumab, assessing IV or SC dosing and selecting the RP2D

6 weeks

3 visits (in-person)

Phase 2a Treatment

3 expansion cohorts at the scRP2D for subjects treated with pembrolizumab and BI-1206, with additional cycles every 3 weeks for up to 2 years

Up to 2 years

Every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years

Treatment Details

Interventions

• BI-1206 (Monoclonal Antibody)
• Pembrolizumab (PD-1 Inhibitor)

Trial Overview The trial is testing BI-1206 in combination with Pembrolizumab for those whose tumors progressed after anti-PD-1/L1 treatment. It's a Phase 1/2a study focusing on safety and effectiveness across different cohorts based on tumor type and previous treatments.

Participant Groups

Group I: BI-1206 + Pembrolizumab 25mg/mL (MK-3475) Experimental Treatment 1 Intervention

BI-1206 administrated either IV or SC + Pembrolizumab 200mg administered IV every third week as a fixed dose will be used.

BI-1206 is already approved in China for the following indications:

Approved in China as BI-1206 for:

• Under clinical trial for Indolent B-Cell Non-Hodgkin Lymphoma

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Oklahoma University , Stephenson Cancer Center Oklahoma City, OK

Sarah Cannon Research Institute Denver, CO

NEXT Oncology San Antonio, TX

HealthPartners Institute - Regions Cancer Care Center, Saint Paul, MN

Who Is Running the Clinical Trial?

BioInvent International AB

Lead Sponsor

Trials

19

Recruited

2,000+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Findings from Research

In a phase II trial involving 15 patients with resectable non-small cell lung cancer (NSCLC), neoadjuvant treatment with pembrolizumab showed a major pathologic response in 27% of patients, indicating promising antitumor activity before surgery.

The treatment was found to be feasible and safe, with only 33% of patients experiencing moderate adverse events, and no postoperative mortality, suggesting that pembrolizumab does not compromise surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience. Eichhorn, F., Klotz, LV., Kriegsmann, M., et al.[2022]

In the KEYNOTE-189 study involving 616 patients with metastatic non-squamous non-small-cell lung cancer, the combination of pembrolizumab and pemetrexed-platinum significantly maintained quality of life (GHS/QOL) scores compared to placebo, with a notable improvement at week 21.

Patients receiving pembrolizumab also experienced a longer median time to deterioration in symptoms like cough and chest pain, although this result was not statistically significant, indicating potential benefits in symptom management with this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes following pembrolizumab or placebo plus pemetrexed and platinum in patients with previously untreated, metastatic, non-squamous non-small-cell lung cancer (KEYNOTE-189): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial. Garassino, MC., Gadgeel, S., Esteban, E., et al.[2020]

Pembrolizumab (KEYTRUDA) was approved by the FDA for treating advanced melanoma, showing an overall response rate of 24% in a trial of 89 patients, with 86% of responses lasting at least 6 months.

While there are potential immune-mediated side effects, the benefits of prolonged tumor response durations were deemed to outweigh these risks, marking an improvement over existing treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma. Chuk, MK., Chang, JT., Theoret, MR., et al.[2021]

Pembrolizumab, a PD-1 inhibitor used in cancer treatment, can lead to rare but serious immune-related adverse events, including type 1 diabetes mellitus, occurring in about 0.2% of cases.

A review of 42 cases revealed that patients may develop diabetic ketoacidosis during treatment, highlighting the need for blood glucose monitoring and awareness of this potential side effect among clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Programmed Cell Death-1 Inhibitor-Induced Type 1 Diabetes Mellitus. Clotman, K., Janssens, K., Specenier, P., et al.[2022]

Pembrolizumab (Keytruda) is an approved treatment for metastatic or locally advanced esophageal and gastroesophageal junction cancer, indicating its efficacy in targeting these specific cancer types.

It is used in combination with platinum- and fluoropyrimidine-based chemotherapy, suggesting a synergistic approach to enhance treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pembrolizumab Approved for Esophageal or Gastroesophageal Cancer. Aschenbrenner, DS.[2023]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions. [2017]

3. England pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes following pembrolizumab or placebo plus pemetrexed and platinum in patients with previously untreated, metastatic, non-squamous non-small-cell lung cancer (KEYNOTE-189): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial. [2020]

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

FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma. [2021]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Pembrolizumab: A Review in Advanced Melanoma. [2022]

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

FDA Approval Summary: Pembrolizumab for the Treatment of Patients with Unresectable or Metastatic Melanoma. [2022]

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

Programmed Cell Death-1 Inhibitor-Induced Type 1 Diabetes Mellitus. [2022]

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

Pembrolizumab Approved for Esophageal or Gastroesophageal Cancer. [2023]

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

FDA Approves Pembrolizumab for BCG-Unresponsive NMIBC. [2021]

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

FDA Approval Summary: Pembrolizumab for Treatment of Metastatic Non-Small Cell Lung Cancer: First-Line Therapy and Beyond. [2022]