Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Kidney Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

All Drugs and Chemicals

Antineoplastic Agents

Amino Acids

Antibodies

Avelumab

Immunoglobulins

Sunitinib

Tyrosine Kinase Inhibitors

Angiogenesis Inhibitors

Growth Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Antineoplastic Agents, Immunological

Tyrosine

First-Line Medication:

* Avelumab 10mg/kg IV on D1 and D15 of every 28 day cycle, until irRECIST 1.1 disease progression criteria is documented.

  * Subjects will have a mandatory an inter-line washout period (14-60 days) before receiving first dose of second-line medication.

Second-Line Medication:

* Sunitinib 50 mg po once daily from D1 to D14 of every 21 day cycle until RECIST 1.1 disease progression criteria is documented.

Subjects who do not have disease progression at end of first-line treatment and are removed due to toxicities or personal decision, may switch to either the second-line therapy or be monitored during the inter-line period until progression, which may be longer than 60 days.

First-Line Medication:

* Sunitinib 50 mg po once daily from D1 to D14 of every 21 day cycle until RECIST 1.1 disease progression criteria is documented.

  * Subjects will have a mandatory inter-line washout period (14-60 days) before receiving first dose of second-line medication.

Second-Line Medication:

* Avelumab 10mg/kg IV on D1 and D15 of every 28 day cycle, until irRECIST 1.1 disease progression criteria is documented.

Subjects who do not have disease progression at end of first-line treatment and are removed due to toxicities or personal decision, may switch to either the second-line therapy or be monitored during the inter-line period until progression, which may be longer than 60 days.

Avelumab 10mg/kg IV over 60 minutes on D1 and D15 of every 28 day cycle

Sunitinib 50 mg once daily from D1 to D14 of every 21 day cycle

Guru Sonpavde, M.D.

This is an open label, randomized phase II trial. Eligible subjects will be randomized in a 1:1 ratio and stratified for known prognostics variables to one of two first-line medication treatment arms. Once disease progression has been documented, and following a required inter-line washout period, subjects will receive either second-line medication treatment or discontinue treatment, per discretion of treating investigator.

OUTLINE: This is a multi-center trial. Eligible subjects will be randomized and stratified to one of two arms:

FIRST-LINE INVESTIGATIONAL TREATMENT ARM A:

* Avelumab 10mg/kg intravenously (IV) on Day 1 (D1) and Day 15 (D15) of every 28 day cycle until documented disease progression per Immune-related Response Evaluation Criteria In Solid Tumors (irRECIST) 1.1

SECOND-LINE INVESTIGATIONAL TREATMENT ARM A:

* Following completion of an inter-line washout period of a minimum of 2 weeks up to a maximum of 60 days (or at the discretion of treating investigator) subjects will receive:

  * Sunitinib 50 mg by mouth (po) once daily from D1 to D14 of every 21 day cycle until documented disease progression per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 OR
  * Discontinue treatment

FIRST-LINE INVESTIGATIONAL TREATMENT ARM B:

* Sunitinib 50 mg po once daily from D1 to D14 of every 21 day cycle until documented disease progression per RECIST 1.1

SECOND-LINE INVESTIGATIONAL TREATMENT ARM B:

* Following completion of an inter-line washout period of a minimum of 2 weeks up to a maximum of 60 days (or at the discretion of treating investigator) subjects will receive:

  * Avelumab 10mg/kg IV on D1 and D15 every 28 day cycle until documented disease progression per irRECIST 1.1 OR
  * Discontinue treatment

NOTE:

Subjects who do not experience disease progression at end of first-line treatment and are removed from first-line treatment due to toxicities or personal decision, may also either receive second-line therapy or be monitored during the inter-line period until progression (which may be longer than 60 days) per discretion of treating investigator.

Radiological disease evaluation assessments will be completed every 12 weeks.

To demonstrate adequate organ function, all screening labs must be obtained within 14 days prior to registration:

Hematological:

* Absolute Neutrophil Count (ANC) ≥ 1.5 K/mm3
* Hemoglobin (Hgb) ≥ 9 g/dL
* Platelets ≥ 100 K/ mm3

Renal:

* Calculated creatinine clearance by Cockcroft-Gault formula ≥ 40 ml/min

Hepatic:

* Bilirubin ≤ 1.5 × upper limit of normal (ULN)
* Aspartate aminotransferase (AST) ≤ 2.5 × ULN
* Alanine aminotransferase (ALT) ≤ 2.5 × ULN

Miscellaneous:

* Urine/serum pregnancy test - Negative

Sunitinib Followed by Avelumab or the Reverse for Metastatic Renal Cell Carcinoma

Randomized Phase II Trial Comparing Sequential First-line Sunitinib and Second-line Avelumab vs First-line Avelumab and Second-line Sunitinib for Metastatic Renal Cell Carcinoma: SUAVE Trial. Hoosier Cancer Research Network GU15-223

Compare PFS1 + PFS2 rates for overall PFS

Compare FFS1 rates for first-line therapy on each arm

Compare OS rates for subjects on each arm

Compare RR and PFS1 of sunitinib vs. avelumab as first-line therapy and PFS2 as second-line therapy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Sunitinib Followed by Avelumab or the Reverse for Metastatic Renal Cell Carcinoma	NCT03035630	Clear-cell Rena... RCC Kidney Cancer Clear-cell Kidn...	Avelumab Sunitinib	18 Years -	Hoosier Cancer Research Network
Sunitinib Followed by Avelumab or the Reverse for Metastatic Renal Cell Carcinoma	NCT03035630	Clear-cell Rena... RCC Kidney Cancer Clear-cell Kidn...	Avelumab Sunitinib	18 Years -	Hoosier Cancer Research Network

Spots Global Cancer Trial Database for igg1 antibody