Intratumoral Vaccination With Intuvax Pre-nephrectomy Followed by Sunitinib Post-nephrectomy vs Sunitinib Post-nephrectomy in Newly Diagnosed Metastatic Renal Cell Carcinoma (mRCC)

NCT02432846 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: IM-2012014-004510-28
• Study Type: interventional
• Target: 88
• Locations: 9 countries
• Sites: 28

Brief Summary

The purpose of this study is to compare tumor response, progression free survival (PFS) and overall survival (OS) in newly diagnosed mRCC patients treated with Intuvax (INN: ilixadencel) pre-nephrectomy followed by Sunitinib post-nephrectomy vs Sunitinib post-nephrectomy patients.

Conditions

Renal Cell Carcinoma, Metastatic

Outcome Measures

Primary Outcomes (4)

• Overall Survival (OS) - Days (FAS)

  OS is the time from randomization until date of death. The patients who were alive at the end of study were followed for survival status (alive/date of death) through medical records, databases and public records according to the time frame below. Due to censored data, estimates of upper 95% CI could not be determined in all reporting groups.

  From the randomization to the date of death, up to 5 years after the last participant's 18-month survival data.

• Overall Survival - Days (PPS)

  OS is the time from randomization until date of death. The patients who were alive at the end of study were followed for survival status (alive/date of death) through medical records, databases and public records according to the time frame below. Due to censored data, upper 95% CI could not be determined in all reporting groups.

  From the randomization to the date of death, up to 5 years after the last patient's 18-month survival data.

• 18-Months' Overall Survival Percentage (FAS)

  The 18-month survival percentage was defined as the percentage of patients alive 18 months after randomization.

  At 18 months (544 days)

• 18-Months' Overall Survival Percentage (PPS)

  The 18-month survival percentage was defined as the percentage of patients alive 18 months after randomization.

  At 18 months (544 days)

Secondary Outcomes (9)

• Progression Free Survival (PFS) From Start of Sunitinib According to RECIST 1.1.

  From Sunitinib-Start to progressive disease or death, up to 18 months.

• Objective Response Rate (ORR) From Start of Sunitinib Treatment and Duration of Response in Each Subgroup.

  From start of sunitinib treatment up to 18 months

• Number of Participants With Specific Best Overall Response

  From start of sunitinib treatment up to 18 months

• Disease Control Rate

  From start of sunitinib treatment up to 18 months

• Duration of Response

  From first date of CR or PR until date of PD or death, up to 18 months.

Study Arms (2)

Intuvax (INN: ilixadencel)+ Nephrectomy+Sunitinib

EXPERIMENTAL

Two Intuvax (INN: ilixadencel) doses (10 million cells/dose) 14 days apart before nephrectomy, followed by Sunitinib treatment post-nephrectomy according to clinical practice until RECIST verified progressive disease or End-of-Study (78 weeks after screening).

Biological: Intuvax (INN: ilixadencel); Drug: Sunitinib

Nephrectomy+Sunitinib

ACTIVE COMPARATOR

Sunitinib treatment post-nephrectomy according to clinical practice until RECIST verified progressive disease or End-of-Study (78 weeks after screening).

Drug: Sunitinib

Interventions

Intuvax (INN: ilixadencel) BIOLOGICAL

Therapeutic dose (10 million cells/dose): allogeneic, pro-inflammatory dendritic cells.

Also known as: COMBIG-DC

Intuvax (INN: ilixadencel)+ Nephrectomy+Sunitinib

Sunitinib DRUG

Cytostatic/cytotoxic drug: protein kinase inhibitor .

Also known as: Sutent

Intuvax (INN: ilixadencel)+ Nephrectomy+Sunitinib; Nephrectomy+Sunitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly (\<6 months) diagnosed RCC (histological/cytological verification is optional) with at least one (1) CT-verified metastasis ≥10mm for which complete metastasectomy is not planned. US patients must have verified clear-cell tumor histology
• Planned resection of primary tumor
• Primary tumor diameter ≥40 mm
• Candidate for first-line therapy with sunitinib initiated 5-8 weeks after nephrectomy
• Female or male ≥18 years of age
• Willing and able to provide informed consent
• Adequate hematological parameters, i.e:
• B-Leukocyte count ≥4.5 x10e9/L
• B-Platelet count ≥150 x10e9/L
• B-Hemoglobin ≥90 g/L
• S-creatinine and S-bilirubin ≤ 1.5 x upper limit of normal (ULN). Serum alanine aminotransferase (S-ALAT) and serum aspartate aminotransferase (S-ASAT) ≤ 2.5 x ULN (or ≤5 in case of liver metastases)
• Female who has been post-menopausal for more than one (1) year or female of childbearing potential agreeing to use a highly efficient method of contraception (i.e. a method with less than 1% failure rate \[e.g. sterilization, hormone implants, hormone injections, some intrauterine devices, or vasectomized partner or combined birth control pills\]) Female of childbearing potential must have a negative from Screening until 90 days after last dose of Intuvax and/or until completed sunitinib treatment whichever occurs later.blood pregnancy test at Screening, and if randomized to vaccination a negative blood or urine pregnancy test within one (1) day before each dose of Intuvax) and must not be lactating.
• or Male agreeing to use condoms from Screening until 90 days after last dose of Intuvax and/or until completed sunitinib treatment whichever occurs later, or male having a female partner who is using a highly efficient method of contraception as described above.

You may not qualify if:

• Life expectancy less than 4 months
• Central nervous system (CNS) metastasis that is symptomatic or progressing or untreated or that required current therapy (e.g. evidence of new or enlarging CNS metastasis or new neurological symptoms attributable to CNS metastases)
• Active autoimmune disease which requires treatment with systemic immunosuppressive agents, e.g. inflammatory bowel disease, multiple sclerosis, sarcoidosis, psoriasis, autoimmune hemolytic anemia, rheumatoid arthritis, systemic lupus erythematosus (SLE), vasculitis, Sjögren's syndrome, scleroderma, autoimmune hepatitis, and other rheumatological diseases
• Treatment with per oral systemic corticosteroids exceeding 10mg/day within seven (7) days before Screening until nephrectomy (inhaled, intranasal and local steroids accepted irrespective of dose)
• Known cardiomyopathy and/or clinical significant abnormal ECG findings at Screening disqualifying the patient from nephrectomy and from subsequent sunitinib treatment
• Karnofsky performance status \<70%
• National Cancer Institute (NCI) Common Terminology criteria for Adverse Events (CTCAE) Grade 3 hemorrhage within 28 days before Screening
• Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
• Clinically significant gastrointestinal abnormalities
• Uncontrolled hypertension, or uncontrolled diabetes mellitus
• Pulmonary embolism within 12 months before screening
• Prior history of invasive cancer within 5 years before screening, except for adequately treated in situ carcinomas or non-melanoma skin cancer
• Ongoing infection that requires parenteral treatment with antibiotics
• Active or latent virus disease (HIV, hepatitis B and hepatitis C)
• Eastern Cooperative Oncology Group (ECOG) performance status \>2 after optimization of analgesics

Sponsors & Collaborators

• Mendus: lead
• TFS Trial Form Support: collaborator
• Accelovance: collaborator

Study Sites (28)

University of Illinois

Chicago, Illinois, 60605, United States

Location

Rush University

Chicago, Illinois, 60612, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Health Partners Institute

Saint Paul, Minnesota, 55101, United States

Location

Duke Cancer Institute

Durham, North Carolina, 27710, United States

Location

University Hospital Olomouc

Olomouc, 779 00, Czechia

Location

Centre Hospitalier Universitaire d'Angers

Angers, 49933, France

Location

Centre Hospitalier Universitaire de Toulouse-Hôpital Rangueil

Toulouse, 31059, France

Location

University of Debrecen

Debrecen, 4032, Hungary

Location

Szent-Györgyi Albert Klinikai Központ

Szeged, 6725, Hungary

Location

Pauls Stradins Clinical University Hospital

Riga, LV-1002, Latvia

Location

Riga East Clinical University Hospital

Riga, LV-1079, Latvia

Location

Niepubliczny Zakład Opieki Zdrowotnej Vesalius Sp. z o.o.

Krakow, 31-108, Poland

Location

Wojewodzki Szpital Specjalistyczny

Lublin, 20-718, Poland

Location

Military Institute of Medicine

Warsaw, 04-141, Poland

Location

Mazowiecki Szpital Onkologiczny

Wieliszew, 05-135, Poland

Location

Hospital Universitari Germans Trias i Pujol

Badalona, 08916, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, 28222, Spain

Location

Hospital Universitari Parc Tauli

Sabadell, 08208, Spain

Location

Sahlgrenska University Hospital

Gothenburg, SE-413 45, Sweden

Location

Karolinska University Hospital

Huddinge, SE-141 86, Sweden

Location

Umeå University Hospital

Umeå, SE-901 85, Sweden

Location

Uppsala University Hospital

Uppsala, SE-751 85, Sweden

Location

The Churchill Hospital

Oxford, OX3 7LE, United Kingdom

Location

Royal Preston Hospital

Preston, PR2 9HT, United Kingdom

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell; Neoplasm Metastasis

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Immunicum Aktiebolag (AB)

info@immunicum.com

+46 (0)8 732 84 00

Study Officials

• Börje Ljungberg, MD, Prof

  Umeå University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2015
• First Posted: May 4, 2015
• Study Start: April 1, 2015
• Primary Completion: January 31, 2021
• Study Completion: January 31, 2021
• Last Updated: August 22, 2022
• Results First Posted: August 22, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2); US (5); PL (4); SE (4); GB (2); LA (2); ES (6); CZ (1); HU (2)