Neoplasms

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Carcinoma, Renal Cell

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Female Urogenital Diseases and Pregnancy Complications

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Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

subcutaneous injections of IMP321 every 14 days for three months (6 injections. Doses tested: 50, 250, 1,250, 6,250 or 30,000 µg

IMP321

Bernard Escudier, M.D

Single-center, open label, non-randomized, fixed dose-escalation, phase 1 study, performed in ambulatory and day-hospital setting

This is a single-center, single-arm, open label, non-randomized, fixed dose-escalation, phase 1 study, performed in ambulatory and day-hospital setting. After a screening period, patients will enter a drug administration period, followed by a 'post-study' period.

Four IMP321 dose levels, 50 µg, 250 µg, 1.250 mg, 6.250 mg and 30 mg will be evaluated in successive cohorts of patients. At any given dose level 3 patients will be administered one subcutaneous dose every 2 weeks for a total of 12 weeks (6 injections in total), separated by 13-day administration-free intervals.

The next (higher) dose level will be dosed to 3 new patients if the previous dose level has been well tolerated. Investigator will decide whether the safety is acceptable by performing an evaluation after the third administration (at week 8) and if the next patients can be included.

The successive cohorts of patients are summarized as follows:

* Cohort A will correspond to a group of 3 patients receiving the 50 µg dose. If safety at this dose level is acceptable as evaluated a fortnight after the 6-week administration, the following cohort will be undertaken.
* Cohort B will correspond to a group of 3 patients receiving the 250 µg dose. If safety at this dose level is acceptable as evaluated a fortnight after the 6-week administration, the following cohort will be undertaken.
* Cohort C will correspond to a group of 3 patients receiving the 1,250 µg dose. If safety at this dose level is acceptable as evaluated a fortnight after the 6-week administration, the following cohort will be undertaken.
* Cohort D will correspond to a group of 3 patients receiving the 1,250 µg dose. If safety at this dose level is acceptable as evaluated a fortnight after the 6-week administration, the following cohort will be undertaken.
* Cohort E will correspond to a group of 3 patients receiving the 6,250 µg dose. The patients will receive their first administration one-by-one with a two-weeks interval. If safety at this dose level is acceptable as evaluated a fortnight after the 6-week administration for the last patient, the following cohort will be undertaken.
* Cohort F will correspond to a group of 3 patients receiving the 6,250 µg dose. If the tolerability of this dose level has been judged acceptable in cohort E, the three patients will receive their first IMP321 injection simultaneously.
* Cohort G will correspond to a group of 3 patients receiving the 30,000 µg dose. The patients will receive their first IMP321 administration one-by-one with a two-weeks interval (+/- 5 days). If safety at this dose level is acceptable as evaluated a fortnight after the 6-week administration for the last patient, the following cohort will be undertaken.
* Cohort H will correspond to a group of 3 patients receiving the 30,000 µg dose. If the tolerability of this dose level has been judged acceptable in cohort E, the three patients will receive their first IMP321 injection simultaneously.

Once the main period of study has been completed, namely two weeks after a cohort is completed, i.e. at week 14, all patients will undergo an ambulatory 'post-study' examination.

Patients of the Cohort B, C, E, F and G will participate in a pharmacokinetic (PK) study and all patients in a pharmacodynamic (PD) study involving additional blood samples.

IMP321 Phase 1 Trial in Metastatic Renal Cell Carcinoma (MRCC)

IMP321 Phase 1 Study in Advanced or Metastatic Renal Cell Carcinoma Patients (P003)

Umanis

Immutep S.A.S.

F. Triebel, Chief Medical Officer

Antineoplastic Agents

All Drugs and Chemicals

Nivolumab

Ipsen Recruitment Enquiries

Ipsen Medical Director

The purpose of this study is to describe the real-life use of Cabometyx® in monotherapy or in combination with nivolumab in Belgium in patients with advanced or metastatic Renal Cell Carcinoma (1st, 2nd and later lines of treatment)

Observational Real-life Study of Cabozantinib in Monotherapy or in Combination With Nivolumab in Advanced Renal Cell Carcinoma (RCC)

REPLICA: Real Patient Life Treatment With Cabozantinib in Monotherapy or in Combination With Nivolumab in Patients With Advanced or Metastatic RCC: a Descriptive and Prospective Non Interventional Study.

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.

Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.

Treatment line will be assessed at baseline. It is a percentage of patients receiving cabozantinib as 1st, 2nd or later lines of treatment or cabozantinib in monotherapy or in combination with nivolumab as 1st line of treatment.

Number of treatment interruptions and reason

Number of patients with permanent discontinuation and reason

Number of patients with schedules other than 1 pill at fixed dose/day for the total treatment period

Number of patients with dose of 60 mg/day, 40 mg/day or 20 mg/day at baseline

Estimation of average daily dose received by subject during the treatment exposure

Changes in quality of life data by comparing changes in scores on Using the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (NFKSI-19). It describes the severity, interference, and frequency rates.

Radiological progression using RECIST 1.1 or investigator assessed or according to local standard of care or death; PFS evaluated at least every 12 weeks under treatment with cabozantinib

Percent of patients with partial and complete response during the treatment with cabozantinib

Percent of patients with stable disease, partial and complete response during the treatment with cabozantinib

Ipsen

Ipilimumab

Participants with advanced or metastatic renal cell carcinoma (aRCC) receiving the combination of nivolumab plus ipilimumab as the first line of systemic therapy

Bristol-Myers Squibb

The purpose of the observational study is to evaluate the safety and effectiveness of combination therapy with nivolumab and ipilimumab in Japanese participants with advanced or metastatic renal cell carcinoma (aRCC) in the real-world setting in Japan.

A Study of Nivolumab Plus Ipilimumab in Participants With Renal Cell Cancer in the Real World Setting in Japan

Japanese Prospective Real World Registry of Nivolumab Plus Ipilimumab in Subjects With Previously Untreated, Advanced or Metastatic Renal Cell Carcinoma (ARCC) Categorized Into IMDC Intermediate/Poor Risks (J-ENCORE)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
IMP321 Phase 1 Trial in Metastatic Renal Cell Carcinoma (MRCC)	NCT00351949	Stage IV Renal ...	IMP321	18 Years -	Immutep S.A.S.
IMP321 Phase 1 Trial in Metastatic Renal Cell Carcinoma (MRCC)	NCT00351949	Stage IV Renal ...	IMP321	18 Years -	Immutep S.A.S.
Observational Real-life Study of Cabozantinib in Monotherapy or in Combination With Nivolumab in Advanced Renal Cell Carcinoma (RCC)	NCT04106349	Advanced or Met...		18 Years -	Ipsen
Observational Real-life Study of Cabozantinib in Monotherapy or in Combination With Nivolumab in Advanced Renal Cell Carcinoma (RCC)	NCT04106349	Advanced or Met...		18 Years -	Ipsen
A Study of Nivolumab Plus Ipilimumab in Participants With Renal Cell Cancer in the Real World Setting in Japan	NCT04043975	Advanced or Met...		20 Years -	Bristol-Myers Squibb

Spots Global Cancer Trial Database for advanced or metastatic renal cell carcinoma