IM-201

• Research type

  Research Study

• Full 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.

• IRAS ID

  172194

• Contact name

  Omi Parikh

• Contact email

  Omi.Parikh@lthtr.nhs.uk

• Sponsor organisation

  Immunicum AB

• Eudract number

  2014-004510-28

• Clinicaltrials.gov Identifier

  IMU001, CRO (TFS) trial code

• Duration of Study in the UK

  2 years, 2 months, 0 days

• Research summary

  The IM-201 study is designed to evaluate the effect and safety of intratumorally administered Intuvax pre-nephrectomy followed by sunitinib post-nephrectomy, compared to sunitinib post-nephrectomy in metastatic renal cell carcinoma patients.
  The patients are randomized in a consecutive order to one (1) of the following two (2) treatment arms when eligibility has been confirmed;

  (i) Two doses of Intuvax (10x106 DCs) administered intratumorally into the primary tumor 14 ±3 days apart followed by nephrectomy at least three (3) days after the second vaccine dose. sunitinib treatment sunitinib treatment initiated five (5) to eight (8) weeks after nephrectomy. Administered dose in accordance with local clinical practice.

  (ii) Sunitinib treatment sunitinib treatment initiated five (5) to eight (8) weeks after nephrectomy. Administered dose in accordance with local clinical practice

  The estimated number of patients to be randomized in the study is 90 (54 intermediate-risk and 36 high-risk). The patients will be randomised in a 2:1, that means two out of three patients will receive the vaccine Intuvax followed by nephrectomy and sunitinib treatment and one out or three patients will go through nephrectomy and receive sunitinib treatment alone.

  Participants assigned to sunitinib treatment alone will visit the clinic 10 times during the study period of maximum 80 weeks; Screening Visit, Nephrectomy visit, sunitinib treatment , follow up visits and End of Study Visit.

  Participants assigned to the vaccination group will receive two doses of Intuvax injected into the primary kidney tumor 14 days apart at two additional visits before nephrectomy. The maximum study period is 80 weeks.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  16/NW/0019

• Date of REC Opinion

  9 Mar 2016

• REC opinion

  Further Information Favourable Opinion