Pembrolizumab for HPV-Related Oropharyngeal Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
HPV-Related Oropharyngeal Cancer+26 MorePembrolizumab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is comparing the effect of adding ipatasertib (a protein kinase B inhibitor) to standard immunotherapy (pembrolizumab) vs. pembrolizumab alone in treating patients with squamous cell cancer of the head and neck. Ipatasertib may stop the growth of tumor cells and may kill them. Pembrolizumab may help the body's immune system attack the cancer. Giving ipatasertib in combination with pembrolizumab may be more effective than pembrolizumab alone in improving some outcomes in patients with recurrent/metastatic squ

Eligible Conditions
  • Squamous Cell Carcinoma of the Head and Neck
  • Recurrent Laryngeal Squamous Cell Carcinoma
  • Recurrent Hypopharyngeal Squamous Cell Carcinoma
  • Recurrent Oropharyngeal Squamous Cell Carcinoma
  • HPV-Related Oropharyngeal Cancer
  • Head and Neck Squamous Cell Carcinoma
  • Head and Neck Squamous Cell Carcinoma (HNSCC)
  • Oral Cancer
  • Stage IVC Hypopharyngeal Carcinoma
  • Stage IVC Laryngeal Cancer
  • Advanced Laryngeal Cancer
  • Stage IV Hypopharyngeal Cancer
  • Stage IV Oropharyngeal Carcinoma
  • Stage IVB Oropharyngeal Carcinoma
  • Stage IVC Oropharyngeal Carcinoma
  • Metastatic Oropharyngeal Squamous Cell Carcinoma
  • Stage IVA Hypopharyngeal Carcinoma
  • Stage IVB Hypopharyngeal Cancer
  • Laryngeal Squamous Cell Carcinoma (Metastatic)
  • Stage IVA Laryngeal Cancer
  • Stage IVA Oropharyngeal Carcinoma
  • Stage IVB Laryngeal Cancer
  • Metastatic Hypopharyngeal Squamous Cell Carcinoma
  • Oral Cavity Squamous Cell Carcinoma (Metastatic)
  • Pathologic Stage IV HPV-Mediated Oropharyngeal Carcinoma

Treatment Effectiveness

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Baseline up to 1 year after the last patient is enrolled

Year 1
Changes in Akt, ERK, and MEK signaling
Changes in immune-cell population in peripheral blood
Changes in the tumor microenvironment by immunophenotyping
Year 1
Progression free survival (PFS)
Year 1
Duration of response
Incidence of adverse events
Overall response rate

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

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

2 Treatment Groups

Arm II (pembrolizumab)
1 of 2
Arm I (ipatasertib, pembrolizumab)
1 of 2

Active Control

Experimental Treatment

48 Total Participants · 2 Treatment Groups

Primary Treatment: Pembrolizumab · No Placebo Group · Phase 2

Arm I (ipatasertib, pembrolizumab)Experimental Group · 3 Interventions: Pembrolizumab, Ipatasertib, Biospecimen Collection · Intervention Types: Biological, Drug, Procedure
Arm II (pembrolizumab)ActiveComparator Group · 2 Interventions: Pembrolizumab, Biospecimen Collection · Intervention Types: Biological, Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Ipatasertib
Not yet FDA approved
Biospecimen Collection
2004
Completed Phase 1
~670

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline up to 1 year after the last patient is enrolled

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,070 Previous Clinical Trials
41,128,774 Total Patients Enrolled
Jacob S ThomasPrincipal InvestigatorCity of Hope Comprehensive Cancer Center LAO

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

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