Bapotulimab (BAY1905254) + Pembrolizumab for Head and Neck Squamous Cell Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Head and Neck Squamous Cell CarcinomaBapotulimab (BAY1905254) + Pembrolizumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new cancer drug combo to see if it's safe, how it affects the body, and if it's effective.

Eligible Conditions
  • Head and Neck Squamous Cell Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

5 Primary · 5 Secondary · Reporting Duration: Up to 58 months

Hour 504
AUC of Bapotulimab after first dose administration (Cycle 1) for cohorts receiving doses ≥ 20 mg
Cmax of Bapotulimab after first dose administration (Cycle 1) for cohorts receiving doses ≥ 20 mg
Hour 504
AUC after multiple dosing (Cycle 3) for cohorts receiving doses ≥ 20 mg
Cmax,md after multiple dosing (Cycle 3) for cohorts receiving doses ≥ 20 mg
Up to 58 months
Best overall response rate
Incidence of positive anti-drug antibody titer for Bapotulimab
Therapeutic procedure
Maximum tolerated dose (MTD) of Bapotulimab
Recommended dose of Bapotulimab for Phase 2
Severity of treatment-emergent AEs (TEAEs) including treatment-emergent serious adverse events (TESAEs), adverse events of special interest (AESIs), and dose-limiting toxicities (DLTs)

Trial Safety

Safety Progress

1 of 3

Side Effects for

Pembrolizumab+EP
54%Neutropenia
45%Anaemia
38%Nausea
34%Alopecia
31%Decreased appetite
29%Constipation
27%Fatigue
26%Thrombocytopenia
22%Leukopenia
21%Diarrhoea
20%Cough
17%Asthenia
17%Dyspnoea
16%Vomiting
14%Pyrexia
14%Dizziness
13%Arthralgia
13%Rash
13%Headache
12%Hypothyroidism
11%Insomnia
11%Pruritus
11%Back pain
10%Weight decreased
9%Hyponatraemia
9%Aspartate aminotransferase increased
8%Oedema peripheral
8%Upper respiratory tract infection
8%Alanine aminotransferase increased
8%Pneumonia
7%Abdominal pain
7%Blood creatinine increased
7%Hypokalaemia
7%Febrile neutropenia
6%Abdominal pain upper
6%Stomatitis
6%Dysgeusia
6%Erythema
6%Dry skin
5%Hyperthyroidism
5%Dyspepsia
5%Dysphagia
5%Chest pain
5%Blood alkaline phosphatase increased
5%Musculoskeletal pain
5%Hypertension
5%Nasopharyngitis
5%Musculoskeletal chest pain
5%Pain in extremity
4%Urinary tract infection
4%Hypotension
2%Death
2%Acute kidney injury
2%Pneumonitis
2%Pulmonary embolism
2%Atrial fibrillation
1%Neutropenic sepsis
1%Inappropriate antidiuretic hormone secretion
1%Diabetes mellitus
1%Hemiparesis
1%Transient ischaemic attack
1%Superior vena cava syndrome
1%Pneumothorax
1%Gastritis
1%Aortic aneurysm
1%Sepsis
1%Pleural infection
1%Infusion related reaction
1%Clostridium difficile colitis
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT03066778) in the Pembrolizumab+EP ARM group. Side effects include: Neutropenia with 54%, Anaemia with 45%, Nausea with 38%, Alopecia with 34%, Decreased appetite with 31%.

Trial Design

3 Treatment Groups

Expansion HNSCC_Combination therapy
1 of 3
Dose escalation_Monotherapy
1 of 3
Dose escalation_Combination therapy
1 of 3

Experimental Treatment

120 Total Participants · 3 Treatment Groups

Primary Treatment: Bapotulimab (BAY1905254) + Pembrolizumab · No Placebo Group · Phase 1

Expansion HNSCC_Combination therapy
Drug
Experimental Group · 1 Intervention: Bapotulimab (BAY1905254) + Pembrolizumab · Intervention Types: Drug
Dose escalation_Monotherapy
Drug
Experimental Group · 1 Intervention: Bapotulimab (BAY1905254) · Intervention Types: Drug
Dose escalation_Combination therapy
Drug
Experimental Group · 1 Intervention: Bapotulimab (BAY1905254) + Pembrolizumab · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 58 months

Who is running the clinical trial?

BayerLead Sponsor
2,150 Previous Clinical Trials
23,874,923 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,673 Previous Clinical Trials
4,958,780 Total Patients Enrolled
Bayer Study DirectorStudy DirectorBayer
1,180 Previous Clinical Trials
4,262,141 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The screening protocol requires the provision of tumor tissue at screening.
You have recurrent or metastatic head and neck squamous cell carcinoma
You are a male or female aged ≥ 18 years.
You have a performance status of 0 to 1.
Dose escalation: All solid tumor types with a likelihood of sensitivity to immunotherapy, as judged by the investigator.
Patients must have received standard therapy or have no standard therapy available or patients have actively refused any treatment which would be regarded standard