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Association details:
Evidence:
Evidence Level:
Sensitive: A2 - Guideline
New
Source:
Excerpt:
Pembrolizumab (for tumors that express PD-L1 [CPS≥1], added category 1 if CPS >20.
Evidence Level:
Sensitive: C1 - Off-label
  (Approved for Non Small Cell Lung Cancer)
New
Excerpt:
Keytruda as monotherapy is indicated for the first line treatment of metastatic non small cell lung carcinoma in adults whose tumours express PD L1 with a ≥ 50% tumour proportion score (TPS) with no EGFR or ALK positive tumour mutations.
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

A clinical trial investigating the safety, tolerability, and therapeutic effects of BNT113 in combination with pembrolizumab versus pembrolizumab alone for patients with a form of head and neck cancer positive for human papilloma virus 16 and expressing the protein PD-L1

Excerpt:
...Patients who have a tumor expressing PD-L1 [CPS ≥1] as determined by the FDA-approved test PD L1 22C3 pharmDx kit performed and evaluated according to the manufacturer's specifications. ...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

First-in-human study of ICT01 in patients with advanced-stage, relapsed/refractory cancer

Excerpt:
...Likewise, the PD activity of ICT01 (by dose and patient population) will include the change from baseline in counts and activation status of Vγ9Vδ2 T cells and other immune cells in the peripheral blood, peripheral blood mononuclear cells (PBMCs) and tumor biopsies, circulating cytokine levels (including IFN gamma, TNF alpha, IL-1ß, IL-2, IL-4, IL-6, IL-8, IL-10, IL-17a and MCP-1), and expression of PD-L1, PD-1 and other immune cell markers in tumor biopsies and PBMCs. ...
More C2 evidence
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Pembrolizumab in HNSCC With Residual Disease After Radiation

Excerpt:
...changes in PD-L1 expression`overall response rate`median progression free survival`overall survival...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Study of WM-A1-3389 in Participants With Advanced or Metastatic Solid Tumors and Non-Small Cell Lung Cancer (MK-3475-E90/KEYNOTE-E90)

Excerpt:
...PD-L1 low or negative expression (tumor proportion score [TPS] < 50%) 3....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Study of Zanzalintinib (XL092) + Pembrolizumab vs Pembrolizumab in Subjects With PD-L1 Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Excerpt:
...- PD-L1 expression level Combined Positive Score (CPS) ≥ 1 by immunohistochemistry (IHC) testing....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

A Study of Pembrolizumab (MK-3475) for First Line Treatment of Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck (MK-3475-048/KEYNOTE-048)

Excerpt:
...PFS is reported here for all participants in the pembro combo arm and control arm with PD-L1 biomarker positive expression defined by immunohistochemistry (IHC) as Combined Positive Score ≥1 (hereafter referred to as CPS ≥1). ...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Pembrolizumab in Combination With Anti-platelet Therapy for Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Excerpt:
...Subject has tumor that expresses PD-L1 (Combined Positive Score [CPS] > 1) as determined by an FDA-approved test or subject has experienced disease progression on or after platinum-containing chemotherapy....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Activity and Safety of Danvatirsen and Pembrolizumab in HNSCC

Excerpt:
...Detectable PD-L1 expression in tumor, defined as CPS ≥20 determined by a Food and Drug Administration-approved test....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Safety, Tolerability, and Preliminary Efficacy of CJRB-101 With Pembrolizumab in Subjects With Selected Types of Advanced or Metastatic Cancer

Excerpt:
...Subjects with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [CPS ≥20] 3....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

pBI-11 & TA-HPV (With Pembrolizumab as Treatment for Patients w/Advanced, PD-L1 CPS≥1, hrHPV+ Oropharyngeal Cancer

Excerpt:
...- hrHPV(+) status (staining with p16 is adequate) and PD-L1 expression (CPS≥1) in tumor based on validated testing methods performed on FFPE tumor tissue (needle core biopsy or resection; fine needle aspiration/biopsy [FNA] cell blocks acceptable if with adequate tissue) at local labs or VUMC labs....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Pembrolizumab (MK-3475) Versus Standard Treatment for Recurrent or Metastatic Head and Neck Cancer (MK-3475-040/KEYNOTE-040)

Excerpt:
...OS for Participants With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Expression Defined by ≥1% Combined Positive Score (CPS)(PD-L1 ≥1% CPS)`Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 for All Participants`PFS Per RECIST 1.1 in Participants With PD-L1 ≥1% CPS`Objective Response Rate (ORR) Per RECIST 1.1 in All Participants`ORR Per RECIST 1.1 in Participants With PD-L1 ≥1% CPS`Duration of Response (DOR) Per RECIST 1.1 in All Participants`DOR Per RECIST 1.1 in Participants With PD-L1 ≥1% CPS`Time to Progression (TTP) Per RECIST 1.1 in All Participants`TTP Per RECIST 1.1 in Participants With PD-L1 ≥1% CPS`PFS Per Modified RECIST in All Participants`PFS Per Modified RECIST 1.1 in Participants With PD-L1 ≥1% CPS`Number of Participants Who Experienced At Least One Adverse Event (AE) in All Participants`Number of Participants Who Experienced At Least One AE in Participants With PD-L1 ≥1% CPS`Number of Participants Who Discontinued Study Treatment Due to an AE in All Participants`Number of Participants Who Discontinued Study Treatment Due to an AE in Participants With PD-L1 ≥1% CPS...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

PembROlizumab With or Without Microbial EcOsystem ThErapeutic 4 (MET4) in Advanced Head and Neck Squamous Cell Carcinoma

Excerpt:
...- Patients must have PD-L1 positive (CPS ≥1) tumor as determined by PD-L1 testing performed at the local laboratory, from a core or excisional biopsy (fine needle aspirate is...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Phase II Trial of Adjuvant Cisplatin and Radiation With Pembrolizumab in Resected Head and Neck Squamous Cell Carcinoma

Excerpt:
...PD-L1 CPS is defined as Combined positivity score (CPS) was calculated by summing the numbers of PD-L1-positive tumor cells and immune cells and dividing by the total number of viable tumor cells. ...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

A Randomized, Double-Blind Phase II Study of Adjuvant Pembrolizumab Versus Placebo in Head and Neck Cancers at High Risk for Recurrence- the PATHWay Study

Excerpt:
...- Availability of tumor tissue (≥ 10 slides) for PD-L1, gene expression profiling (GEP), and additional testing....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Study of MK-3475 (Pembrolizumab) in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma After Treatment With Platinum-based and Cetuximab Therapy (MK-3475-055/KEYNOTE-055)

Excerpt:
...Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants`Participants with a strong PD-L1 expression status were evaluated for ORR by RECIST 1.1. ...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Testing What Happens When an Immunotherapy Drug (Pembrolizumab) is Added to Radiation or Given by Itself Compared to the Usual Treatment of Chemotherapy With Radiation After Surgery for Recurrent Head and Neck Squamous Cell Carcinoma

Excerpt:
...Disease free survival`PD-L1 expression...