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Table 3 Clinical trials of FGFR-TKI combination immunotherapy

From: Unleashing the potential of combining FGFR inhibitor and immune checkpoint blockade for FGF/FGFR signaling in tumor microenvironment

NCT Number

Phases

Status

Tumor

Intervention1

Intervention 2

Intervention 3

Intervention 4

Treatment line

Gene state

NCT05614739

Phase 1

Recruiting

Urinary Bladder Neoplasms

Neoplasm Metastasis

Ureteral Neoplasms

LOXO-435

LOXO-435

+Pembrolizumab

  

After standard therapies

FGFR3-altered

NCT04601857

Phase 2

Recruiting

Advanced and Metastatic Urothelial Cancer

Futibatinib

+Pembrolizumab

   

First-line

FGFR3 Mutation;

FGFR1-4 Fusion/Rearrangement

NCT02401542

Phase 1/2

Terminated

Locally Advanced or Metastatic Urothelial Cell Carcinoma

Urinary Bladder Disease

Urological Diseases

Vofatamab

+Docetaxel

Docetaxel

+Placebo

Vofatamab

 

Second or subsequent

FGFR3 Mutant/Fusion

NCT05267470

Phase 1

Recruiting

Squamous-Cell Non-Small-Cell Lung Cancer

Bemarituzumab

+Docetaxel

Bemarituzumab

Bemarituzumab

+Pembrolizumab

+Carboplatin

+Paclitaxel

 

Intervention 1: Second or subsequent

Intervention2: Third or subsequent

Intervention3: First or subsequent

FGFR2b Overexpression

NCT05564416

Phase 2

Recruiting

Localized Bladder Cancer

Erdafitinib

Erdafitinib

+Atezolizumab

  

Neoadjuvant

FGFR2/3 Alterations

NCT04604132

Phase 1/2

Completed

Gastric Adenocarcinoma

Derazantinib

Derazantinib

+Paclitaxel

+Ramucirumab

Derazantinib

+Atezolizumab

Paclitaxel

+Ramucirumab

Second or subsequent

FGFR2 Fusions/Rearrangements/Amplifications;

FGFR1-3 Mutations/Short variants

NCT05174650

Phase 2

Recruiting

Intrahepatic Cholangiocarcinoma

Atezolizumab

+Derazantinib

   

First or Second line

FGFR2 Fusions/Rearrangements

NCT05510427

Phase 1

Not yet recruiting

Cholangiocarcinoma

Liver Cancer

Infigratinib

+Atezolizumab

+Bevacizumab

   

Second or subsequent

FGFR2 Fusion/Amplification

NCT04045613

Phase 1/2

Completed

Urothelial Carcinoma

Derazantinib

Derazantinib

+Atezolizumab

Derazantinib

+/-Atezolizumab

 

Intervention 1: Second or subsequent

Intervention2: First-line

Intervention3: Second-line

FGFR1-3 Mutations/Short variants and Rearrangements/fusions

NCT05004974

Phase 2

Not yet recruiting

Advanced Non Small Cell Lung Cancer

Sintilimab

+Pemigatinib

   

First-line

FGFR Mutation

NCT03473743

Phase 1/2

Active, not recruiting

Urothelial Carcinoma

Erdafitinib

+Cetrelimab

Erdafitinib

+Cetrelimab

+Cisplatin/Carboplatin

Erdafitinib

 

Intervention 1: Any line

Intervention2/3: First-line

FGFR Alterations

NCT04828486

Phase 2

Recruiting

Advanced Hepatocellular Carcinoma

Futibatinib

+Pembrolizumab

   

Second-line

FGF-19 Positive

NCT03473756

Phase 1b/2

Active, not recruiting

Locally Advanced or Metastatic Urothelial Carcinoma

Rogaratinib + Atezolizumab

   

First-line

FGFR1/3 mRNA expression

NCT02325739

Phase 1/2

Completed

Solid Malignancies

FGF401

FGF401

+PDR001

  

Intervention 1: After standard therapies Intervention2: Third or subsequent

 

NCT02925533

Phase 1

Terminated

Bladder Cancer

Vofatamab

+Pembrolizumab

   

Second or

subsequent

 

NCT03123055

Phase 1/2

Terminated

Locally Advanced or Metastatic Urothelial Cell Carcinoma

Vofatamab

Vofatamab

+Pembrolizumab

  

First-line

 

NCT04003610

Phase 2

Terminated

Metastatic Urothelial Carcinoma

Unresectable Urothelial Carcinoma

Pemigatinib

+Pembrolizumab

Pembrolizumab

Gemcitabine

+Carboplatin

 

First-line

 

NCT04699643

Phase 1/2

Recruiting

Advanced Solid Tumors

EVER4010001

+Pembrolizumab

   

After standard therapies

 

NCT05111626

Phase 3

Recruiting

Gastric Cancer

Gastroesophageal Junction Adenocarcinoma

Bemarituzumab

+Nivolumab

+mFOLFOX6

Nivolumab

+mFOLFOX6

+Placebo

  

First-line

 

NCT05173142

Phase 1/2

Recruiting

Solid Tumor

HMPL-453 monotherapy

HMPL-453 + chemotherapy /anti-PD-1 mAb

  

After standard therapies

 

NCT05253053

Phase 1/2

Recruiting

Advanced Solid Tumor

TT-00420

TT-00420

+Atezolizumab

TT-00420

+nab-paclitaxel

 

After standard therapies

 

NCT05322577

Phase 1

Recruiting

Gastric Cancer

Gastroesophageal Junction Cancer

Bemarituzumab

+CAPOX

Bemarituzumab

+CAPOX

+Nivolumab

Bemarituzumab

+SOX

+Nivolumab

 

First-line

 

NCT05369286

Phase 1

Recruiting

Solid Tumor

MAX-40279-01

+Toripalimab