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Vaccine

DSP-7888 Dosing Emulsion for Kidney Cancer

Phase 1 & 2
Waitlist Available
Research Sponsored by Sumitomo Pharma America, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up radiographic imaging every 6 weeks for 24 weeks and then every 12 weeks until progression for an average of 12 months
Awards & highlights

Study Summary

This trial is testing a new cancer drug, given as an infusion, in combination with either of two checkpoint inhibitors. The first part of the trial will enroll cancer patients with different types of solid tumors to test for safety and effectiveness of the drug. If the drug is found to be safe, the second part of the trial will specifically enroll ovarian cancer patients to further assess effectiveness.

Eligible Conditions
  • Kidney Cancer
  • Bladder Cancer
  • Peritoneal Cancer
  • Ovarian Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~radiographic imaging every 6 weeks for 24 weeks and then every 12 weeks until progression, up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and radiographic imaging every 6 weeks for 24 weeks and then every 12 weeks until progression, up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determination of the Recommended Phase 2 Dose (RP2D) by Assessing Dose-limiting Toxicities (DLTs).
Number of Patients With Adverse Events and Serious Adverse Events
Phase II: The Objective Response Rate (ORR) of DSP-7888 Dosing Emulsion Administered With Pembrolizumab in Patients With Platinum-resistant Ovarian Cancer (PROC).
Secondary outcome measures
Phase II: 6-month Progression-free Survival (PFS) of Ombipepimut-S in Combination With Pembrolizumab
Phase II: Assessment of the Duration of Response (DOR) of Ombipepimut-S in Combination With Pembrolizumab
Phase II: Assessment of the Progression-free Survival (PFS) of Ombipepimut-S in Combination With Pembrolizumab
+13 more

Side effects data

From 2021 Phase 3 trial • 221 Patients • NCT03149003
75%
Injection site reaction
75%
Cough
50%
Decreased appetite
50%
Pyrexia
50%
Seizure
50%
Fatigue
50%
Vomiting
50%
Headache
25%
Hyperhidrosis
25%
Alopecia
25%
Dizziness
25%
Diarrhoea
25%
Gastrooesophageal reflux disease
25%
Hemiparesis
25%
Adrenal insufficiency
25%
Dry mouth
25%
Nausea
25%
Stridor
25%
Dysphagia
25%
Injection site erythema
25%
Hypomagnesaemia
25%
Brain oedema
25%
Anxiety
25%
Thrombocytopenia
25%
Hyperacusis
25%
Hypertension
25%
Oedema peripheral
25%
Confusional state
25%
Insomnia
25%
Mental status changes
25%
Psychotic disorder
25%
Epistaxis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part 1 - Arm 1: DSP-7888 Dosing Emulsion Plus Bevacizumab
Part 2 - Arm 1: DSP-7888 Dosing Emulsion Plus Bevacizumab
Part 2 - Arm 2: Bevacizumab

Trial Design

2Treatment groups
Experimental Treatment
Group I: DSP-7888 Dosing Emulsion in combination with PembrolizumabExperimental Treatment2 Interventions
Group II: DSP-7888 Dosing Emulsion in combination with NivolumabExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DSP-7888 Dosing Emulsion
2017
Completed Phase 3
~250
Nivolumab
2014
Completed Phase 3
~4750
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

Sumitomo Pharma America, Inc.Lead Sponsor
236 Previous Clinical Trials
52,673 Total Patients Enrolled
Sumitomo Dainippon Pharma Oncology, IncLead Sponsor
41 Previous Clinical Trials
6,581 Total Patients Enrolled
Sumitomo Pharma Oncology, Inc.Lead Sponsor
44 Previous Clinical Trials
6,902 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study of DSP-7888 Dosing Emulsion in Combination With Immune Checkpoint Inhibitors in Adult Patients With Advanced Solid Tumors
2017. "A Study of DSP-7888 Dosing Emulsion in Combination With Immune Checkpoint Inhibitors in Adult Patients With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03311334.
~6 spots leftby Apr 2025
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