Neoplasms

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Recurrence

Hypoxia

Carcinoma, Renal Cell

Kidney Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Disease Attributes

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

Antineoplastic Agents

All Drugs and Chemicals

Belzutifan

Immunomodulating Agents

Naïve participants will receive 120 mg belzutifan and 60 mg cabozantinib orally once daily (QD) at the same time.

Participants who have received prior immunotherapy will receive 120 mg belzutifan and 60 mg cabozantinib orally QD at the same time.

Cabozantinib tablets administered orally.

Cabozantinib

Medical Director

This is an open-label Phase 2 study which will evaluate the efficacy and safety of belzutifan in combination with cabozantinib in participants with advanced ccRCC. Belzutifan and cabozantinib will be administered orally once daily.

Belzutifan in combination with cabozantinib administered orally once daily

A Trial of Belzutifan (PT2977, MK-6482) in Combination With Cabozantinib in Patients With Clear Cell Renal Cell Carcinoma (ccRCC) (MK-6482-003)

A Phase 2 Trial of PT2977 in Combination With Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

ORR is defined as the percentage of participants with a best confirmed response of Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) as determined by the investigator using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).

PFS is defined as the interval from the start of study treatment until the earlier of the first documentation of disease progression determined by RECIST 1.1 or death from any cause.

DOR is defined as the interval from the first documentation of response, as determined by RECIST 1.1, to the earlier of the first documentation of disease progression or death from any cause, and calculated for participants with a best confirmed response of CR (disappearance of all target lesions) or PR (≥30% decrease in the sum of diameters of target lesions).

TTR is defined as the interval from the start of study treatment to the first documentation of a response, as determined by RECIST 1.1, and calculated for participants with a best confirmed response of CR or PR.

OS is defined as the interval from the start of treatment to the death of the participant from any cause.

An AE is defined as any untoward medical occurrence in a participant regardless of its causal relationship to study treatment. An AE can be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of the study drug, whether or not it is considered to be study drug related. Included in this definition are any newly occurring events and any previous condition that has increased in severity or frequency since the administration of study drug.

Blood samples for the determination of belzutifan concentration will be collected at pre-specified timepoints before and after treatment administration.

Blood samples for the determination of belzutifan metabolite concentration will be collected at pre-specified timepoints before and after treatment administration.

Blood samples for the determination of cabozantinib concentration will be collected at pre-specified timepoints before and after treatment administration.

Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Behaviors and Mental Disorders

Quality of Life

Pembrolizumab

Avelumab

Axitinib

Sunitinib

Concomitant coaching (24 weeks) Pro-active TEAE (Treatment emergent adverse events) management Cancer therapy according to Standard of Care (SOC) QoL assessments/ primary endpoint FKSI-15

Re-activeTEAE management (SOC) Cancer therapy according to Standard of Care (SOC) QoL assessments/ primary endpoint FKSI-15

The corner stones of the pro-active coaching are as follows:

* Patient education:

  * Information on nature and severity of treatment emergent AEs
  * information about remedies for TEAEs
  * propagation and explanation of tests and treatment decisions
  * Patient instruction on self-care and preventive measures
* Preemptive AE treatment strategies
* Supervision of reported ADR severity, ADR mitigation strategies according to recommendations of the PREPARE protocol and cancer treatment modification by treating physician in close collaboration with the coach

Concomitant coaching

Mischo Kursar, Dr.

Johanna Homfeld

Heribert Stauder, MD

heribert.stauder@barmherzige-regensburg.de

Severine Banek, Dr.

Heinz-Gert Höffkes, Prof.

Arne Strauß, Dr.

Matthias Groschek, MD

Yon-Dschun Ko, Prof.

Viktor Grünwald, Prof.

Rene Mager, Dr.

Nina Heidger, Dr.

Andreas Janitzky, Dr.

Ralf Eckert, Dr.

Matthias Schulze, Dr.

Nils Gilbert, Dr.

Stefan Mahlmann, Dr.

Ludwig Fischer von Weikersthal, Dr.med.

Fritz Maiwirth, Dr.med.

Maike de Wit, Prof. Dr.

Lutz Jacobasch, Dr.med.

Johannes Mohm, Dr. med.

Manfred Wirth, Prof. Dr.

Ulla Frfr. von Verschuer, Dr.

Mark-Oliver Zahn, Dr.

Michael Metz, Dr.

Philipp Ivanyi, Dr.

Thorsten Werner

Richard Hansen, Dr. med.

Ursula Vehling-Kaiser, Dr. med.

Jan Schröder, PD Dr.

Martin Bögemann, PD Dr.

Marinela Augustin, Dr.med.

Andreas Hübner, Dr.

Ulrich Banhardt, Dr. med.

Anke Wortmann, Dr.

Viktor Grünwald, Prof. Dr.

The primary objective of the trial is to determine the effect of a 24-week concomitant coaching on patient reported outcomes of patients receiving standard treatment for mRCC with sunitinib or a combination of pembrolizumab + axitinib or avelumab + axitinib in first line therapy.

The goal of our study is to define the benefit of proactive coaching in mRCC, when compared to a reactive approach, which is considered the standard of care.

Patients in the Coaching Arm A will be trained continuously at personal interactions of coach and patient (Face-to Face meetings as well as telephone contacts). The patient is educated on nature and severity of treatment emergent Adverse events (TEAE) of sunitinib or a combination of pembrolizumab + axitinib or avelumab + axitinib in first line therapy.

Quality of Life (QoL) is assessed during sunitinib treatment in both arms (Arm A Coaching and Arm B non Coaching).

Role of PRoactivE Coaching on PAtient REported Outcome in Advanced or Metastatic RCC Treated With Sunitinib or a Combination of Pembrolizumab + Axitinib or Avelumab + Axitinib in First Line Therapy

A Phase III Study Testing the Role of PRoactivE Coaching on PAtient REported Outcome in Advanced or Metastatic Renal Cell Carcinoma Treated With Sunitinib or a Combination of Pembrolizumab + Axitinib or Avelumab + Axitinib in First Line Therapy

Rate of responders to concomitant coaching assessed by the (Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI)) FKSI-15 questionnaire.

Objective Response Rate (ORR) according to RECIST 1.1 criteria

Duration of treatment (coaching and cancer treatment)

Rate of patients receiving treatment beyond progression

% of patients with treatment discontinuation due to specific ADRs (e.g. hand-foot syndrome, diarrhea, stomatitis, fatigue, hypertension)

* Frequency/incidence, severity, percentage reduction, time-to-event of ADRs, AEs and specific TEAEs (e.g. hand-foot syndrome, diarrhea, stomatitis, fatigue, hypertension)
* change of grade 3/4 ADRs

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Trial of Belzutifan (PT2977, MK-6482) in Combination With Cabozantinib in Patients With Clear Cell Renal Cell Carcinoma (ccRCC) (MK-6482-003)	NCT03634540	Renal Cell Carc... Clear Cell Rena... Kidney Cancer Renal Cancer Renal Cell Carc... Renal Cell Canc... Renal Cell Carc... Renal Cell Canc... Kidney	Belzutifan Cabozantinib	18 Years -	Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Role of PRoactivE Coaching on PAtient REported Outcome in Advanced or Metastatic RCC Treated With Sunitinib or a Combination of Pembrolizumab + Axitinib or Avelumab + Axitinib in First Line Therapy	NCT03013946	Renal Cell Carc... Renal Cell Canc...	Concomitant coa...	18 Years -	AIO-Studien-gGmbH
A Trial of Belzutifan (PT2977, MK-6482) in Combination With Cabozantinib in Patients With Clear Cell Renal Cell Carcinoma (ccRCC) (MK-6482-003)	NCT03634540	Renal Cell Carc... Clear Cell Rena... Kidney Cancer Renal Cancer Renal Cell Carc... Renal Cell Canc... Renal Cell Carc... Renal Cell Canc... Kidney	Belzutifan Cabozantinib	18 Years -	Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Role of PRoactivE Coaching on PAtient REported Outcome in Advanced or Metastatic RCC Treated With Sunitinib or a Combination of Pembrolizumab + Axitinib or Avelumab + Axitinib in First Line Therapy	NCT03013946	Renal Cell Carc... Renal Cell Canc...	Concomitant coa...	18 Years -	AIO-Studien-gGmbH

Spots Global Cancer Trial Database for renal cell cancer, recurrent