AzTrials
AzTrials

Renal Cell Carcinoma, MetastaticPhase 2MERECANCT02432846

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

A Phase 2 study testing Intuvax (INN: ilixadencel) and Sunitinib in people with Renal Cell Carcinoma, Metastatic, run by Mendus at 28 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Cell Carcinoma, Metastatic
What is being tested?
Intuvax (INN: ilixadencel) and Sunitinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
28 sitesin 9 countries
Study dates
Apr 2015to 31 Jan 2021
Phase
Phase 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

  • 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
Show all 13Show fewer
  • 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.

Who cannot join

  • 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%
Show all 25Show fewer
  • 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
  • Abnormal and clinical significant coagulation parameters at the discretion of the Investigator, i.e.:
  • Prothrombin Time - International Normalized Ratio (PT-INR)
  • Activated Partial Thromboplastin Time (APTT) patients being treated with anticoagulants are excluded if the coagulation parameters are outside the therapeutic intervals as described in the summary of product characteristics (SmPC) / United States prescribing information (USPI) for the administered treatment
  • Known major adverse reaction/event in connection with previously made vaccination (e.g. asthma, anaphylaxis or other serious reaction)
  • Known hypersensitivity or allergy sunitinib or to chemically related products or likely to be exacerbated to by any component of the study products
  • Prior systemic antitumour therapy within 28 days before Screening Visit. However, local radiation therapy to any area except for the abdominal/retroperitoneal area including the kidney tumour is allowed
  • Exposure to other investigational products within 28 days prior to Screening Visit
  • patients on anticoagulants for whom temporarily stop and start, supported by low molecular weight heparin (or other anticoagulation therapy at the discretion of the investigator and or per local standard of care) during vaccination and nephrectomy, is not an option
  • History of alcohol or substance abuse
  • Any reason that, in the opinion of the Investigator, contraindicates that the patient participates in the study

Trial locations and contacts

28 sites in 9 countries.

28 sites in 9 countries

Spain6 sites

  • Hospital Universitari Germans Trias i Pujol

    Badalona, 08916

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, 28222

  • Hospital Universitari Parc Tauli

    Sabadell, 08208

Other trials in Spain

United States5 sites

  • University of Illinois

    Chicago, Illinois, 60605

  • Rush University

    Chicago, Illinois, 60612

  • Duke Cancer Institute

    Durham, North Carolina, 27710

  • University of Iowa

    Iowa City, Iowa, 52242

  • Health Partners Institute

    Saint Paul, Minnesota, 55101

Other trials in United States

Poland4 sites

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

    Krakow, 31-108

  • Wojewodzki Szpital Specjalistyczny

    Lublin, 20-718

  • Military Institute of Medicine

    Warsaw, 04-141

  • Mazowiecki Szpital Onkologiczny

    Wieliszew, 05-135

Other trials in Poland

Sweden4 sites

  • Sahlgrenska University Hospital

    Gothenburg, SE-413 45

  • Karolinska University Hospital

    Huddinge, SE-141 86

  • Umeå University Hospital

    Umeå, SE-901 85

  • Uppsala University Hospital

    Uppsala, SE-751 85

Other trials in Sweden

France2 sites

  • Centre Hospitalier Universitaire d'Angers

    Angers, 49933

  • Centre Hospitalier Universitaire de Toulouse-Hôpital Rangueil

    Toulouse, 31059

Other trials in France

Hungary2 sites

  • University of Debrecen

    Debrecen, 4032

  • Szent-Györgyi Albert Klinikai Központ

    Szeged, 6725

Other trials in Hungary

Latvia2 sites

  • Pauls Stradins Clinical University Hospital

    Riga, LV-1002

  • Riga East Clinical University Hospital

    Riga, LV-1079

Other trials in Latvia

United Kingdom2 sites

  • The Churchill Hospital

    Oxford, OX3 7LE

  • Royal Preston Hospital

    Preston, PR2 9HT

Other trials in United Kingdom

Czechia1 site

  • University Hospital Olomouc

    Olomouc, 779 00

Other trials in Czechia

About this study

Official title: An Open-label, Randomized, Controlled, Multicenter, Phase II Study Evaluating Safety and Efficacy of Intratumorally Administered Intuvax Pre-nephrectomy Followed by Sunitinib Post-nephrectomy, Compared to Sunitinib Post-nephrectomy in Metastatic Renal Cell Carcinoma Patients

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.

Read the detailed description

Patients, all planned for nephrectomy, will be stratified according to the Heng risk criteria (high risk patients vs. intermediate risk patients) and randomized in a 2:1 ratio to receive Intuvax (INN: ilixadencel)+ Sunitinib or Sunitinib alone.

Two doses of Intuvax (INN: ilixadencel) will be administered in to the primary tumour before nephrectomy. The control group will be scheduled for nephrectomy directly.

All patients will start Sunitinib treatment 5-8 weeks after operation.

Results from the phase I study, together with the results reported in the literature on the use of autologous dendritic cells (DCs) in combination with Sunitinib encourage Immunicum aktiebolag (AB) to further investigate the possibility of exploiting Intuvax (INN: ilixadencel) 10 million cells/dose when combined with Sunitinib for the treatment of mRCC patients.

Being tested
Intuvax (INN: ilixadencel), Sunitinib
Medical subject headings
Carcinoma, Renal Cell, Neoplasm Metastasis

What participants receive

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

  • Intuvax (INN: ilixadencel)Biological

    Also called COMBIG-DC

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

  • SunitinibDrug

    Also called Sutent

    Cytostatic/cytotoxic drug: protein kinase inhibitor .

Study groups in NCT02432846
Study groupRoleWhat they receive
Intuvax (INN: ilixadencel)+ Nephrectomy+SunitinibExperimentalTwo 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).
Receives: Biological: Intuvax (INN: ilixadencel); Drug: Sunitinib
Nephrectomy+SunitinibActive comparatorSunitinib treatment post-nephrectomy according to clinical practice until RECIST verified progressive disease or End-of-Study (78 weeks after screening).
Receives: Drug: Sunitinib

What is being measured

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

  1. 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.

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

  2. 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.

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

  3. 18-Months' Overall Survival Percentage (FAS)

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

    Measured: At 18 months (544 days)

  4. 18-Months' Overall Survival Percentage (PPS)

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

    Measured: At 18 months (544 days)

Secondary outcomes (9)

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

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by radiographic assessment: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

    Due to the large amount of censored data, estimates of median and/or a 95% CI could not be reliably determined in all reporting groups.

    Baseline data are reported for the safety data set (all patients randomized) whereas PFS is analyzed for the full analysis set (FAS). Two patients in the safety data set were not included in the FAS since they withdrew prior to start of treatment.

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

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

    Objective response rate was defined as the percentage of patients with complete response (CR) and partial response (PR).Tumor response was evaluated centrally according to the RECIST 1.1 guideline.

    Measured: From start of sunitinib treatment up to 18 months

  3. Number of Participants With Specific Best Overall Response

    The best overall response is the best response recorded from the start of the treatment sunitinib until disease progression/recurrence; taking as reference for progressive disease (PD) the smallest measurements recorded since the treatment started. In general, the patient's best response assignment depended on the achievement of the measurement criteria.

    Measured: From start of sunitinib treatment up to 18 months

  4. Disease Control Rate

    Best overall response (CR, PR or SD) evaluated from Sunitinib-Start for patients with available data.

    Measured: From start of sunitinib treatment up to 18 months

  5. Duration of Response

    The duration of response was calculated for only those patients who responded. It was the time from first objective response to first observed progression of disease or death if the death was due to disease progression (whichever came first).

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

  6. Duration of Clinical Benefit

    Disease control rate (DCR) also called Clinical Benefit Rate, was defined as the proportion of patients with CR or PR or SD.

    Measured: From first date of clinical benefit (CR, PR or SD) until date of PD or death, up to 18 months.

  7. Duration of Stable Disease

    The duration of SD was calculated for only those patients who exhibited a best response of SD response as per RECIST v1.1. It was the time from first SD response to first observed progression of disease or death if the death was due to disease progression (whichever came first), up to 18 months.

    Measured: From first date of SD until PD or date of death, up to 18 months.

  8. Time to Progression (TTP)

    Due to the large amount of censored data, estimate of upper 95% CI could not be reliably determined in all reporting groups.

    Measured: Time from Sunitinib-Start to date of either PD according to RECIST 1.1 or clinical progression as evaluated by the Investigator, up to 18 months.

  9. Percentage of Tumor Area With Infiltrating Cluster of Differentiation 8+ (CD8+) T-cells

    Relative number of tumor-infiltrating CD8+ T-cells in the resected primary tumor compared to number of infiltrating CD8+ T-cells in available diagnostic pre-biopsy (sample from either primary tumor or metastasis), was not to be evaluated as described in the protocol due to missing pre-biopsy samples). Instead an automated and validated quantification of percentage of CD8+ tissue in delineated tumor area was made.

    Measured: At resection of primary tumor.

Timeline

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

  1. First posted4 May 2015 (estimated)
  2. Study startApr 2015
  3. Primary completion31 Jan 2021
  4. Study completion31 Jan 2021

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02432846
Sponsor's protocol ID
IM-201
Other IDs
2014-004510-28, 2014
Acronym
MERECA
Status last verified
Jul 2022
First submitted
15 Apr 2015
Last updated
22 Aug 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Intuvax (INN: ilixadencel) and Sunitinib in people with Renal Cell Carcinoma, Metastatic, run by Mendus at 28 sites in 9 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 13 inclusion and 25 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: finished, as of the sponsor's last update on 22 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in Spain, United States, Poland, Sweden, France and 4 more countries. 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 phase mean?

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 22 Aug 2022). 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?

Overall Survival (OS) - Days (FAS) (time frame: From the randomization to the date of death, up to 5 years after the last participant's 18-month survival data.). The study lists 4 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 NCT02432846.

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 22 Aug 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in