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Renal Cell Carcinoma (RCC)Phase 1/2NCT03311334

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

A Phase 1/2 study testing DSP-7888 Dosing Emulsion, Nivolumab and Pembrolizumab in people with Renal Cell Carcinoma (RCC) and Urothelial Carcinoma, run by Sumitomo Pharma America, Inc. at 19 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
DSP-7888 Dosing Emulsion, Nivolumab and Pembrolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
19 sitesin 2 countries
Study dates
14 Dec 2017to 29 Nov 2022
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must fulfill each of the following requirements:
  • Phase 1b Dose Search Part Only: A histologically or cytologically confirmed cancer that is metastatic and is approved to be treated with nivolumab or pembrolizumab with the following origins:
  • Nivolumab: unresectable or metastatic melanoma, metastatic NSCLC, advanced RCC, recurrent or metastatic squamous cell carcinoma of the head and neck, locally advanced or metastatic urothelial carcinoma, hepatocellular carcinoma, MSI-H/dMMR colorectal cancer
  • Pembrolizumab: unresectable or metastatic melanoma, metastatic NSCLC, recurrent or metastatic squamous cell carcinoma of the head and neck, locally advanced or metastatic urothelial carcinoma, unresectable or metastatic MSI-H/dMMR solid tumors, recurrent locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma, recurrent or metastatic cervical cancer
  • In addition, the following requirements must be fulfilled:
  • Patients must not be considered eligible for a potentially curative resection.
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  • Patients who are eligible for PD-1 therapy based on either criterion (i) or (ii) below:
  • Patients progressed on their prior treatment before initiating treatment on current study, OR (ii) Patients who are currently being treated with nivolumab or pembrolizumab and have achieved at least stable disease (SD), and who, in the judgment of their treating physicians, could benefit from the addition of DSP-7888 Dosing Emulsion vaccine to improve or maintain their response.
  • Phase 1b Enrichment Cohort Only: Patients with locally advanced or metastatic RCC or urothelial carcinoma who have experienced disease progression per iRECIST (iCPD) during or within 3 months of last dose of the most recent prior anti-PD-1/ PD-L1-based treatment
  • Patients must be positive for at least 1 of the following human leukocyte antigens:
  • HLA-A*02:01
  • HLA-A*02:06
  • HLA-A*24:02
  • HLA-A*03:01
  • HLA-B*15:01
  • ≥ 18 years of age
  • Eastern Cooperative Oncology group (ECOG) performance status of 0 or 1
  • Patients must be able to provide archival tumor tissue with sufficient tumor tissue, or patients must consent to undergo tumor biopsy to acquire sufficient tissue before first administration of study
  • Females of childbearing potential must have a negative serum pregnancy test
  • Male or female patients of child-producing potential must agree to use contraception or use prevention of pregnancy measures (true abstinence) during the study and for 6 months (for females and males alike) after the last dose
  • Total bilirubin of ≤ 2.0 mg/dL (≤ 3.0 mg/dL for patients with known Gilbert's syndrome)
  • Aspartate aminotransferase (AST) ≤ 3.0 × the upper limit of normal (ULN) or < 5 × ULN if considered to be due to liver metastases
  • Alanine transaminase (ALT) ≤ 3.0 × the upper limit of normal (ULN) or < 5 × ULN if considered to be due to liver metastases
  • Glomerular Filtration Rate > 40 mL/min
  • Multigated acquisition (MUGA) scan or echocardiogram with left ventricular ejection fraction (LVEF) > 40%
  • Life expectancy ≥ 3 months
  • Patients must be willing to provide a signed and dated ICF
  • Patients eligible for inclusion must meet all of the following criteria:
  • 1. Patients must be female ≥ 18 years of age, able to understand study procedures, and subsequently agreed to participate in the study by providing a written informed consent obtained prior to any prescreening and screening procedures that are not standard of care 2.
  • Patients must be positive for at least 1 of the following human leukocyte antigens (HLA):
  • HLA-A*02:01 b. HLA-A*02:06 c. HLA-A*24:02 d. HLA-A*03:01 e. HLA-B*15:01
  • 3. Patients must have histologically diagnosed ovarian, fallopian tube, or primary peritoneal cancer with predominantly high-grade (Grade 2 or 3) serous epithelial features 4. Patients must be considered platinum resistant to last administered platinum-based therapy, defined as patient relapsed within 6 months after last dose of platinum-based therapy 5. Patients must have completed at least 1 but no more than 4 prior lines of therapy for serous epithelial ovarian, fallopian tube, or primary peritoneal cancer;
  • Maintenance is not considered a separate line of treatment (even if patients with BRCA mutation positive received PARP-inhibitor following induction therapy with a platinum doublet including bevacizumab, etc.)
  • Neoadjuvant and adjuvant systemic therapy will be counted as one line of therapy
  • Patients must have received at least one platinum-based therapy
  • 6. Patients must have progression disease after last therapy and have measurable disease according to RECIST (v1.1).
  • 7. Patients must have an ECOG performance status of 0 or 1. 8. Patients must have adequate organ function, defined as follows:
  • Hematological:
  • Absolute neutrophil count (ANC) ≥ 1,500/μL (without granulocyte-colony stimulating factor (G-CSF))
  • Platelets ≥ 100,000/μL (without transfusion)
  • Hemoglobin ≥ 9.0 g/dL (without transfusion)
  • Renal:
  • Serum Creatinine OR estimated glomerular filtration rate using the Cockcroft-Gault equation ≤ 1.5 × the upper limit of normal (ULN) OR 40 mL/min using the Cockcroft-Gault equation for patients with creatinine levels > 1.5 × ULN
  • Hepatic:
  • Serum total bilirubin ≤ 1.5 ULN
  • Aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤ 2.5 × ULN OR ≤ 5 × ULN for patients with liver metastases
  • Cardiac:
  • Multigated acquisition (MUGA) scan or echocardiogram with left ventricular ejection fraction (LVEF) ≥ 40%.
  • QTcF (QT corrected based on Fridericia's equation) interval < 480 msec
  • Coagulation:
  • International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 × ULN
  • Activated Partial Thromboplastin Time (aPTT) or Partial Thromboplastin Time (PTT) ≤ 1.5 × ULN
  • 9. Patients must provide a fresh tissue biopsy, if medically feasible, or archival tissue as either a formalin-fixed and paraffin embedded FFPE) block or newly sectioned tissue on charged slides (equivalent to approximately 8-23 slides sectioned at 4-5μm thickness) 10. Patients of childbearing potential must have a negative serum or urine pregnancy test at screening 11. Patients must be either postmenopausal, free from menses > 12 months, surgically sterilized, or willing to use adequate contraception to prevent pregnancy or must agree to abstain from heterosexual activity throughout the study, starting with enrollment through 6 months after the last dose of study treatment 12. Life expectancy ≥ 3 months 13. Patients who had stayed on the last treatment for at least 12 weeks without any evidence of progression

Who cannot join

  • Patients with any of the following will be excluded from the study:
  • Anticancer chemotherapy (including molecular targeted drugs), immunotherapy, radiotherapy, or investigational agents within 4 weeks of the first dose of DSP 7888 Dosing Emulsion
  • Major surgery within 4 weeks prior to study treatment
  • Patients who have received a live vaccine within 4 weeks prior to the first dose
  • Any known, untreated brain metastases; patients with treated brain metastases must be clinically stable for 4 weeks after completion of treatment for brain metastases and have radiographic image documentation of stability. Patients must have no clinical symptoms from brain metastases and not have required systemic corticosteroids > 10 mg/day prednisone or equivalent for at least 2 weeks prior to the first dose of study drug
  • Patients who have multifocal glioblastoma
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  • Pregnant or breastfeeding
  • Patients who have an active autoimmune disease requiring immunosuppression > 10 mg/day prednisone or equivalent a. Patients with controlled hyperthyroidism must be negative for thyroglobulin and thyroid peroxidase antibodies and thyroid stimulating immunoglobulin prior to study drug administration
  • Patients who have interstitial lung disease or active, non-infectious pneumonitis
  • Known hypersensitivity to a component of protocol therapy:
  • Patients with known hypersensitivity to any of the components of DSP-7888 Dosing Emulsion.
  • Patients with known hypersensitivity to nivolumab or pembrolizumab are excluded from receiving combination therapy that includes the agent to which they are hypersensitive
  • Uncontrolled concurrent illness including, but not limited to: ongoing or active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy; clinically significant non-healing or healing wounds; symptomatic congestive heart failure; unstable angina pectoris; severe and/or uncontrolled cardiac arrhythmia; significant pulmonary disease; or, psychiatric illness/social situations that would limit compliance with study requirements
  • Patients with a history of another primary cancer with the exception of: (a) curatively resected non-melanoma skin cancer; (b) curatively treated cervical carcinoma in situ; (c) localized prostate cancer not requiring systemic therapy; and d) any another cancer from which the patient has been disease free for ≥ 2 years that, in the opinion of the Investigator and medical monitor for the Sponsor, will not affect patient outcome in the setting of the current diagnosis
  • Patients who have a QTcF (QT corrected based on Fridericia's equation) interval > 480 msec (CTCAE = Grade 2) or other factors that increase the risk of QT prolongation or arrhythmic events (e.g. heart failure, hypokalemia, family history of long QT interval syndrome) at screening
  • Patients who have a medical history of frequent or sustained ventricular ectopy
  • Patients who have, in the opinion of the treating Investigator, any concurrent conditions that could pose an undue medical hazard or interfere with the interpretation of the study results
  • Known history of human immunodeficiency virus (HIV) infection, active hepatitis B, or untreated hepatitis C
  • Patients who have baseline signs and symptoms consistent with clinically significant, decreased pulmonary function: (1) blood saturation oxygen level (SpO2) < 90% at rest on room air; (2) dyspnea at rest or required supplemental oxygen within 2 weeks of study enrollment
  • Patients with any of the following will be excluded from the study:
  • Primary platinum refractory patients defined as patients who experienced disease progression during the treatment with first-line platinum therapy
  • Patients with a known, untreated brain metastasis. Patients with treated brain metastases must be clinically stable for 4 weeks after completion of treatment for brain metastases and have radiographic image documentation of stability. Patients must have no clinical symptoms from brain metastases and not have required systemic corticosteroids > 10 mg/day prednisone or equivalent for at least 4 weeks prior to the first dose
  • Patients who have received prior treatment with any other anti-PD-1, or PD-L1 or PD-L2 agent or an antibody or a small molecule targeting other immuno-regulatory receptors or mechanisms (examples of such drugs include but are not limited to antibodies against CTLA-4, LAG-3, IDO, PD-L1, IL-2R, GITR)
  • Patients who have received prior treatment with any other Wilms Tumor 1 (WT1)-related agents including peptide vaccine, dendric cell vaccine, and gene therapy
  • Patients who have received treatment for ovarian cancer within the following time frame prior to the first dose of the study
  • Cytotoxic chemotherapy, hormonal therapy; ≤ 3 weeks
  • Targeted therapy except for monoclonal antibody; ≤ 3 weeks
  • Immune therapy, biologic therapy (e.g. antibodies); ≤ 4 weeks
  • Other investigational agents: ≤ 4 weeks
  • Radiation therapy (except for localized radiotherapy for analgesic purpose) ≤ 4 weeks
  • Radiation therapy (localized radiotherapy for analgesic purpose) ≤ 1 week
  • Major surgery regardless of reason ≤ 4 weeks.
  • Patients who have received a live vaccine within 4 weeks prior to the first dose.
  • Any known additional malignancy that is progressing or requires active treatment with the exception of:
  • curatively treated basal cell or squamous cell carcinoma of skin
  • curatively treated superficial bladder cancer, carcinoma in situ of the cervix,
  • any another cancer from which the patient has been disease free for ≥ 3 years without any active treatment that, in the opinion of the Investigator and medical monitor for the Sponsor, will not affect patient's outcome in the setting of the current diagnosis.
  • Patients who have not recovered to < CTCAE Grade 2 or baseline from toxic effect (with exception of alopecia and/or neuropathy) of prior cancer therapy.
  • Patients who have an active autoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance dose of corticosteroids (> 10 mg/day prednisone or equivalent) or any other forms of immunosuppressive therapy within 7 days prior to the first dose of study drug.
  • Positive serology for HIV infection, active hepatitis B, or hepatitis C
  • Patients who have a known history of bacillus tuberculosis (TB).
  • Patients with impaired cardiac function or clinically significant cardiac disease;
  • New York Hospital Association Class III or IV cardiac disease, including preexisting clinically significant ventricular arrythmia, congestive heart failure, or cardiomyopathy
  • Unstable angina pectoris ≤ 6 months before study participation
  • Myocardial infarction or stroke ≤ 6 months before study participation
  • Patients who have an interstitial lung disease or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management
  • Patients with active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
  • Patients with any psychiatric condition, substance abuse disorder, or social situation that would interfere with a patient's cooperation with the study requirements and schedule
  • Patients with any condition that would, in the investigator's judgment, interfere with full participation including administration of study drugs, attending required visits or interfere with interpretation of study data
  • Patients who are pregnant or breastfeeding
  • Patients who have known hypersensitivity to DSP-7888 Dosing Emulsion, pembrolizumab, their components, or their excipients
  • Patient has dyspnea at rest (CTCAE ≥ Grade 3) or has required supplemental oxygen within 2 weeks of study enrollment
  • Patients with history of bowel obstruction related to underlying disease within 3 months prior to the first dose of study treatment

Trial locations and contacts

19 sites in 2 countries.

19 sites in 2 countries

United States17 sites

  • Rocky Mountain Cancer Centers

    Aurora, Colorado, 80012

  • St Vincent Frontier Cancer Center

    Billings, Montana, 59102

  • UC Health, LLC

    Cincinnati, Ohio, 45229

  • Ohio State University

    Columbus, Ohio, 43210

  • Mary Crowley Cancer Research

    Dallas, Texas, 75251

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • West Cancer Clinic

    Germantown, Tennessee, 38138

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Horizon Oncology Research

    Lafayette, Indiana, 47905

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Norton Cancer Institute

    Louisville, Kentucky, 40241

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

  • AdventHealth Cancer Institute

    Orlando, Florida, 32804

  • UC San Francisco Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94143

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • Summit Cancer Centers

    Spokane, Washington, 99208

  • Arizona Oncology Associates, PC - HOPE

    Tucson, Arizona, 85711

Other trials in United States

Canada2 sites

  • Centre hospitalier de l'Université de Montréal (CHUM)

    Montreal, Quebec, H2X 0A9

  • SMBD Jewish General Hospital

    Montreal, Quebec, H3T 1E2

Other trials in Canada

About this study

Official title: A Phase 1b/2, Multicenter, Open-Label Study of DSP-7888 Dosing Emulsion in Combination With Immune Checkpoint Inhibitors Nivolumab or Pembrolizumab in Adult Patients With Advanced Solid Tumors

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.

Being tested
DSP-7888 Dosing Emulsion, Nivolumab, Pembrolizumab
Keywords
DSP-7888, Nelatimotide, Adegramotide, immune checkpoint inhibitor, cancer vaccine, WT1, ICI, Wilms Tumor 1, Ombipepimut-S, nivolumab, Opdivo, pembrolizumab, Keytruda, Ovarian cancer, Platinum-resistant ovarian cancer, PROC, Serous epithelial ovarian cancer, High-grade serous epithelial ovarian cancer, HGSOC, Fallopian tube cancer
Medical subject headings
Carcinoma, Renal Cell, Carcinoma, Transitional Cell, Fallopian Tube Neoplasms, Wilms Tumor, Ovarian Neoplasms, Kidney Neoplasms, Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DSP-7888 Dosing EmulsionDrug

    Also called Ombipepimut-S (adegramotide and nelatimotide)

    DSP-7888 Dosing Emulsion will be administered intradermally (ID) every 7 days until cycle 3, and then every 14 days for combination with Nivolumab arm or every 21 days for combination with Pembrolizumab arm.

  • NivolumabDrug

    Also called Opdivo

    Nivolumab will be administered in the approved dose and schedule starting on Day 29 of the study.

  • PembrolizumabDrug

    Also called Keytruda

    Pembrolizumab will be administered in the approved dose and schedule starting on Day 22 of the study.

Study groups in NCT03311334
Study groupRoleWhat they receive
DSP-7888 Dosing Emulsion in combination with NivolumabExperimentalNot described
Receives: Drug: DSP-7888 Dosing Emulsion; Drug: Nivolumab
DSP-7888 Dosing Emulsion in combination with PembrolizumabExperimentalNot described
Receives: Drug: DSP-7888 Dosing Emulsion; Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Patients With Adverse Events and Serious Adverse Events

    Measured: From the date of signing informed consent until 30 days after last dose for an average of 3 months.

  2. Determination of the Recommended Phase 2 Dose (RP2D) by Assessing Dose-limiting Toxicities (DLTs).

    The RP2D was based on the data collected during phase 1b.

    Measured: 28 days

  3. Phase II: The Objective Response Rate (ORR) of DSP-7888 Dosing Emulsion Administered With Pembrolizumab in Patients With Platinum-resistant Ovarian Cancer (PROC).

    Defined as the proportion of patients who have achieved confirmed Complete Response or Partial Response by RECIST v1.1 based on investigator assessment.

    Measured: Radiographic imaging every 6 weeks for 24 weeks and then every 12 weeks until progression for an average of 12 months

Secondary outcomes (16)

  1. Phase Ib: The Objective Response Rate (ORR) of DSP-7888 Dosing Emulsion Administered With Pembrolizumab or Nivolumab

    Defined as the proportion of patients who have achieved confirmed complete response (CR) or partial response (PR) evaluated using RECIST v1.1 and iRECIST.

    Measured: At 4 weeks for the nivolumab arm and at 6 weeks for the pembrolizumab arm and then at Weeks 12, 18, and 24 after the first dose of the DSP-7888 dosing emulsion

  2. Phase Ib: The Disease Control Rate (DCR) of DSP-7888 Dosing Emulsion Administered With Pembrolizumab or Nivolumab

    Defined as the percentage of patients who have achieved best overall response (BOR) of complete response (CR), partial response (PR), or stable disease (SD) per RECIST v1.1 and iRECIST.

    Measured: At 4 weeks for the nivolumab arm and at 6 weeks for the pembrolizumab arm and then at Weeks 12, 18, and 24 after the first dose of the DSP-7888 dosing emulsion

  3. Phase Ib: Assessment of the Duration of Response (DOR) of Ombipepimut-S in Combination With Nivolumab or Pembrolizumab

    DOR is defined as the time from first documentation of response until the time of first documentation of disease progression by RECIST v1.1 and iRECIST or death by any cause.

    Measured: At week 4 for patients on the nivolumab arm and week 6 for patients on the pembrolizumab arm. Thereafter weeks 12, 18 and 24 and every 12 weeks until progression or death.

  4. Phase Ib: Progression-free Survival (PFS) of DSP-7888 Dosing Emulsion Administered With Pembrolizumab or Nivolumab

    The percentage of participants with a complete response or partial response who have measurable disease at baseline imaging.

    Measured: Radiographic imaging every 6 weeks for 24 weeks and then every 12 weeks until progression for an average of 12 months

  5. Phase Ib: The 6-month Progression-free Survival (PFS) Rate of Ombipepimut-S in Combination With Nivolumab or Pembrolizumab

    Defined as the proportion of patients who neither progressed by RECIST (v.1.1) nor died before 6 months (24 weeks) from the first study treatment

    Measured: 6 months

  6. Phase Ib: Percentage of Patients With Overall Survival (OS) When Treated With Ombipepimut-S in Combination With Nivolumab or Pembrolizumab

    Measured: 12 months

  7. Phase II: Assessment of the Duration of Response (DOR) of Ombipepimut-S in Combination With Pembrolizumab

    Defined as the time from the first documentation of a response (CR or PR) until time of first documentation of disease progression by RECIST v1.1 or death by any cause.

    Measured: Radiographic imaging every 6 weeks for 24 weeks and then every 12 weeks until progression up to 24 months.

  8. Phase II: Disease Control Rate of Ombipepimut-S in Combination With Pembrolizumab

    Defined as the percentage of patients who have achieved best overall response (BOR) of complete response, partial response, or stable disease per RECIST (v.1.1)

    Measured: Radiographic imaging every 6 weeks for 24 weeks and then every 12 weeks until progression, up to 24 months.

  9. Phase II: Assessment of the Progression-free Survival (PFS) of Ombipepimut-S in Combination With Pembrolizumab

    Defined as the time from the date of the first dose of study treatment to the earlier date of assessment of progression by RECIST v.1.1, or death by any cause

    Measured: Radiographic imaging every 6 weeks for 24 weeks and then every 12 weeks until progression, up to 24 months

  10. Phase II: 6-month Progression-free Survival (PFS) of Ombipepimut-S in Combination With Pembrolizumab

    PFS is defined as the time from the date of the first dose of study treatment to the earlier date of assessment of progression by RECIST (v.1.1), or death by any cause

    Measured: 6 months

  11. Phase II: Overall Survival of Patients Treated With Ombipepimut-S in Combination With Pembrolizumab

    Defined as the time from the date of first dose of study treatment to the date of death by any cause

    Measured: Every 3 months from last dose of study treatment up to 24 months.

  12. Phase II: Immune Objective Response Rate (iORR) of Ombipepimut-S in Combination With Pembrolizumab

    Defined as the percentage of patients who have achieved confirmed immune complete response (iCR) or immune partial response (iPR), evaluated using iRECIST based on investigator's assessment.

    Measured: Up to 24 months

  13. Phase II: Immune Disease Control Rate (iDCR) of Ombipepimut-S in Combination With Pembrolizumab

    Defined as the percentage of patients who have achieved best overall response of iCR, iPR, or immune stable disease (iSD), per iRECIST

    Measured: Up to 24 months

  14. Phase II: Immune Progression-free Survival (iPFS) of Ombipepimut-S in Combination With Pembrolizumab

    Defined as the time from the date of the first dose of study treatment to the earlier date of assessment of progression by iRECIST or death by any cause

    Measured: Up to 24 months

  15. Phase II: Immune Duration of Response (iDOR) of Ombipepimut-S in Combination With Pembrolizumab

    Defined as the time from the first documentation of response (iCR or iPR) until time of first documentation of disease progression by iRECIST, or death by any cause

    Measured: Up to 24 months

  16. Phase II: Evaluation of the Safety and Tolerability of Ombipepimut-S in Combination With Pembrolizumab

    Demonstrated by the number of participants with adverse events and serious adverse events

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2017
  2. Study start14 Dec 2017
  3. Primary completion19 Oct 2022
  4. Study completion29 Nov 2022

Why it stopped: Sponsor's decision to terminate development of the program.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03311334
Sponsor's protocol ID
BBI-DSP7888-102CI
Status last verified
Mar 2024
First submitted
9 Oct 2017
Last updated
18 Apr 2024
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing DSP-7888 Dosing Emulsion, Nivolumab and Pembrolizumab in people with Renal Cell Carcinoma (RCC) and Urothelial Carcinoma, run by Sumitomo Pharma America, Inc. at 19 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 53 inclusion and 53 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients With Adverse Events and Serious Adverse Events (time frame: From the date of signing informed consent until 30 days after last dose for an average of 3 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03311334.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.

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