A Study of DSP-7888 Dosing Emulsion in Combination With Immune Checkpoint Inhibitors in Adult Patients With Advanced Solid Tumors

  • STATUS
    Recruiting
  • End date
    Feb 15, 2024
  • participants needed
    84
  • sponsor
    Sumitomo Dainippon Pharma Oncology, Inc
Updated on 15 September 2021
metastatic melanoma
cancer
hla-a
filgrastim
granulocyte colony stimulating factor
systemic therapy
serum pregnancy test
measurable disease
carcinoma
squamous cell carcinoma
gilbert's syndrome
international normalized ratio
colony stimulating factor
gm-csf
metastasis
neutrophil count
liver metastasis
pet scan
pembrolizumab
blood transfusion
bevacizumab
g-csf
adjuvant therapy
aptt
thromboplastin
nivolumab
primary cancer
cancer chemotherapy
adenocarcinoma
solid tumour
ovarian cancer
solid neoplasm
fallopian tube
metastatic gastric cancer
metastatic urothelial carcinoma
immunomodulator
immunostimulant
immunostimulants
health screening
metastatic cervical cancer
immunomodulators
metastatic renal cell carcinoma
platinum doublet
formalin-fixed paraffin-embedded
peritoneal cancer
primary peritoneal carcinoma
cancer of the ovary
immunologic adjuvant
gastroesophageal junction adenocarcinoma

Summary

This is a Phase 1b/2, open-label, multicenter study of DSP-7888 Dosing Emulsion in combination with checkpoint inhibitors (nivolumab or pembrolizumab) in adult patients with solid tumors, that consists of 2 parts: dose search part of the study (Phase 1b and Phase 1b Enrichment Cohort) and the dose expansion part of the study (Phase 2). In Phase 1b of this study there will be 2 arms: Arm 1 and Arm 2. In Arm 1, there will be 6 to 12 patients who will be dosed with DSP-7888 Dosing Emulsion and nivolumab and in Arm 2 there will be 6 to 12 patients who will be dosed with DSP-7888 Dosing Emulsion and pembrolizumab. In addition, an enrichment cohort of a further 10 patients who have locally advanced or metastatic Renal Cell Carcinoma or Urothelial Cancer with primary or acquired resistance to previous checkpoint inhibitors will be enrolled into Phase 1b of the study to help evaluate the preliminary antitumor activity of DSP-7888 Dosing Emulsion at the safe dose level identified in the dose-search part of the study, and will be dosed with DSP-7888 Dosing Emulsion and nivolumab, or DSP-7888 Dosing Emulsion and pembrolizumab, as per the investigator's preference. At the safe, recommended dose determined in Phase 1b, platinum-resistant ovarian cancer (PROC) patients will be enrolled in Phase 2 of the study with DSP-7888 Dosing Emulsion, exploring the combination with pembrolizumab (Arm 2). In Phase 2, approximately 40 patients with PROC will be initially enrolled; additional patients may be enrolled to further assess anti-tumor activities, but the total sample size will not exceed 60 patients. This brings the total maximum study population to approximately 84 patients.

Details
Condition Non-Small Cell Lung Cancer, Cervical Cancer, Adenocarcinoma, Colorectal Cancer, Disorders of cervix NOS, Malignant neoplasm of kidney, Rectal disorder, Uterine Cancer, Cancer, Fallopian Tube Cancer, melanoma, Transitional cell carcinoma, Renal Cell Carcinoma, skin cancer, HEPATIC NEOPLASM, HEPATOCELLULAR CARCINOMA, Gastropathy, Gastric Cancer, Stomach Discomfort, Metastatic Melanoma, Colon Cancer Screening, Cancer/Tumors, Rectal Disorders, Colon cancer; rectal cancer, Primary Peritoneal Cancer, Squamous Cell Carcinoma of the Head and Neck, Head and Neck Squamous Cell Carcinoma, Ewing's Family Tumors, Gastroesophageal Junction Adenocarcinoma, Adenocarcinoma of the Gastroesophageal Junction, Squamous Cell Carcinoma of Head and Neck, Gastric Carcinoma, Cancer (Pediatric), Urothelial Neoplasm, Platinum Resistant Ovarian Cancer, Kidney Cancer, Malignant Melanoma, Liver Cancer, Malignant Adenoma, Stomach Cancer, Neoplasms, Renal Cell Cancer, Renal Cancer, Urothelial Carcinoma, Microsatellite Instability-high or Mismatch Repair Deficient (MSI-H/dMMR), Microsatellite Instability-high or Mismatch Repair Deficient (MSI-H/dMMR), Microsatellite Instability-high or Mismatch Repair Deficient (MSI-H/dMMR), Serous Epithelial Ovarian Cancer, Microsatellite Instability-high or Mismatch Repair Deficient (MSI-H/dMMR), cervical carcinoma, clear cell renal cell carcinoma, colorectal neoplasm, gastric cancers, colorectal cancers, nsclc, fallopian tube cancers, cervical cancer, uterine, carcinoma of the cervix uteri, carcinoma of the cervix, cervix cancer, cancer of the cervix, carcinoma of cervix, liver cell carcinoma, cancer, colorectal, colorectal tumor, tumors, colorectal, Microsatellite Instability-high or Mismatch Repair Deficient (MSI-H/dMMR), Microsatellite Instability-high or Mismatch Repair Deficient (MSI-H/dMMR), Microsatellite Instability-high or Mismatch Repair Deficient (MSI-H/dMMR)
Treatment Pembrolizumab, Nivolumab, Atezolizumab, DSP-7888 Dosing Emulsion
Clinical Study IdentifierNCT03311334
SponsorSumitomo Dainippon Pharma Oncology, Inc
Last Modified on15 September 2021

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