Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Nivolumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Recommended dose (RD) and schedule of belvarafenib and cobimetinib selected based on the safety data, tolerability, pharmacokinetics, and anti-tumor activity tested in dose-finding phase followed by an expansion phase.

Recommended dose (RD) and schedule of belvarafenib and cobimetinib plus nivolumab IV infusion every 4 weeks (Q4W) in a run-in phase followed by an expansion phase

Belvarafenib

Once daily (QD) or three times weekly (TIW) for 21 days, 7 days off

Cobimetinib

Clinical Trials

This study will evaluate the safety, pharmacokinetics, and activity of belvarafenib as a single agent and in combination with either cobimetinib or cobimetinib plus nivolumab in patients with NRAS-mutant advanced melanoma who have received anti-PD-1/PD-L1 therapy.

The study will evaluate three treatment regimens in three arms: a belvarafenib monotherapy arm (Belva arm); a belvarafenib plus cobimetinib arm (Belva + Cobi arm) in an initial dose-finding phase followed by an expansion phase and a belvarafenib plus cobimetinib plus nivolumab arm (Belva + Cobi + Nivo arm) in a run-in phase followed by an expansion phase.

A Study to Evaluate the Safety and Activity of Belvarafenib as a Single Agent and in Combination With Either Cobimetinib or Cobimetinib Plus Nivolumab in Patients With NRAS-mutant Advanced Melanoma.

A Phase Ib, Open-Label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Activity of Belvarafenib as a Single Agent and in Combination With Either Cobimetinib or Cobimetinib Plus Nivolumab in Patients With NRAS-Mutant Advanced Melanoma Who Have Received Anti-PD-1/PD-L1 Therapy

Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0

Defined as the percentage of participants with a CR or PR on two consecutive occasions \>/= 4 weeks apart, as determined by the investigator according to RECIST v1.1

Defined as the time from the first study treatment to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1

Defined as the time from the first occurrence of a confirmed objective response to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1

Defined as the time from the first study treatment to death from any cause

Genentech, Inc.

Cetuximab

Regimen: twice daily (BID), continuous dosing for HM95573, once daily (QD) 21 days, 7 days off for cobimetinib

HM95573, cobimetinib

Regimen: twice daily (BID), continuous dosing for HM95573

HM95573, cetuximab

Regimen: Recommended dose (RD) and schedule selected based on the data of safety, tolerability, pharmacokinetics, and anti-tumor activity tested in Stage 1

Regimen: Expansion dose of HM95573 selected based on the data of safety and tolerability tested in Stage 1b

This study evaluates the safety, tolerability and pharmacokinetics of HM95573 In combination with either cobimetinib or cetuximab in patients with locally advanced or metastatic solid tumors.

This is a Phase Ib, open-label, multicenter dose-escalation study designed to assess the safety, tolerability, and pharmacokinetics of oral dosing of HM95573 in combination with either cobimetinib or cetuximab in patients with histologically/cytologically confirmed, locally advanced, or metastatic solid tumors with RAS- or RAF-mutation for which standard therapies either do not exist or have proven ineffective or intolerable. Treatment will continue until disease progression, unacceptable toxicity, any other discontinuation criterion is met.

There are two stages of this study: Stage 1 and 1b, standard 3+3 dose escalation, and Stage 2, an indication-specific dose expansion. Stage 1 is designed to establish the combination MTD for cobimetinib and HM95573. Stage 1 consists of concurrent administration of cobimetinib and HM95573. Stage 1b, is designed to select the combination dose of cetuximab and HM95573 for expansion stage.

In Stage 2 expansion cohort I and II, the RD of cobimetinib and HM95573 with different dosing schedules or regimens might be investigated (which may be≤ MTDs established during dose escalation) in indication-specific expansion cohorts. Stage 2 expansion cohort III will further characterize the safety and tolerability of cetuximab in combination with HM95573.

HM95573 in Combination With Either Cobimetinib or Cetuximab in Patients With Locally Advanced or Metastatic Solid Tumors

A Phase Ib, Open-label, Multicenter, Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of HM95573 in Combination With Either Cobimetinib or Cetuximab in Patients With Locally Advanced or Metastatic Solid Tumors

Hanmi Pharmaceutical Company Limited

Anti-Arrhythmia Agents

Vasodilator Agents

Analgesics

Amino Acids

Ado-Trastuzumab Emtansine

Trastuzumab

Atezolizumab

Ipatasertib

Alectinib

Pralsetinib

Entrectinib

Inavolisib

Adenosine

Maytansine

Tubulin Modulators

Antimitotic Agents

Immunotoxins

Immunoconjugates

Immunologic Factors

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Phosphoinositide-3 Kinase Inhibitors

Tyrosine

Participants with metastatic or advanced solid tumors, with the exception of NSCLC will receive entrectinib once daily in repeated 28-day cycles at a dose of 600 milligram per day (mg/day) for adults and pediatric participants with a body surface area (BSA) \>/= 1.51 squaremeter (m2). The total dose of daily entrectinib administration for pediatric participants with BSA\<1.51 m2 will be lower.

Participants with metastatic or advanced solid tumors will receive entrectinib once daily in repeated 28-day cycles at a dose of 600 mg/day for adults and pediatric participants with a BSA \>/= 1.51 m2. The total dose of daily entrectinib administration for pediatric participants with BSA\<1.51 m2 will be lower.

Participants with metastatic or advanced solid tumors, with the exception of NSCLC, will receive alectinib at a dosage of 600 mg orally twice a day (BID), taken with food, in repeated 28-day cycles.

Participants with metastatic or advanced solid tumors will receive atezolizumab intravenously (IV) at a fixed dose for participants aged \>/= 18 years, and 15 mg/kg (maximum 1200 mg) for participants aged \< 18 years on Day 1 of each 21-day cycle.

Note: Cohort D has been closed for enrollment

Participants with metastatic or advanced solid tumors will receive ipatasertib orally once daily (QD) at the starting dose of 400 mg in repeated 28-day cycles until the participant experiences disease progression, intolerable toxicity, or withdraws consent. For participants 12-17 years of age, ipatasertib will be administered at the starting dose of 200 mg for participants \<35 kg, 300 mg for participants \>/= 35 and \<45 kg, 400 mg for those \>/=45 kg orally QD in repeated 28-day cycles until the participant experiences disease progression, intolerable toxicity, or withdraws consent.

Note: Cohort E has been closed for enrollment

Participants with metastatic or advanced solid tumors will receive trastuzumab emtansine IV at a dose of 3.6 mg/kg every 21 days.

Note: Cohort F has been closed for enrollment

Participants with metastatic or advanced solid tumors will receive idasanutlin at a dose of 250 mg orally QD on Days 1-5 of each 28-day cycle.

Note: Cohort G has been closed for enrollment

Participants with metastatic or advanced solid tumors will receive GDC-0077 QD at a starting dose of 9 mg by mouth (PO) in repeated 28-day cycles.

Note: Cohort H has been closed for enrollment

Participants with BRAF class II mutant/fusion-positive tumors (adults and adolescents ≥ 40 kg) will receive 400 mg belvarafenib by mouth (PO) BID (twice a day) with adequate water (more than 200 mL). One cycle consists of 28 days. Administration of belvarafenib should occur BID on every day of each 28-day cycle.

Note: Cohort I has been closed for enrollment

Participants with BRAF class III mutant-positive tumors(adults and adolescents ≥ 40 kg) will receive 400 mg belvarafenib by mouth (PO) BID (twice a day) with adequate water (more than 200 mL). One cycle consists of 28 days. Administration of belvarafenib should occur BID on every day of each 28-day cycle.

Note: Cohort J has been closed for enrollment

Participants with RET fusion-positive tumors will self-administer Pralsetinib orally at home (except on clinic days) on a continuous daily dosing regimen at a dose of 400 mg/day (four 100-mg capsules per day) for adult and pediatric patients ≥ 12 and \< 18 years of age. A treatment cycle consists of 4 weeks (28 days).

Note: Cohort K has been closed for enrollment

Participants with KRAS G12C-positive tumors will self-administer GDC-6036 orally at home (except on clinic days).

Participants with ATM Loss of Function tumors will self-administer Camonsertib orally at home (except on clinic days).

Participants with SETD2 Loss of Function tumors will self-administer Camonsertib orally at home (except on clinic days).

Adults and pediatric participants with a BSA \>/= 1.51 m2: entrectinib will be self-administered by participants orally at home at a dose of 600 mg/day (three 200-mg capsules per day). Pediatric participants with a BSA \< 1.51 m2: entrectinib will be administered orally at home in mini-tablet formulation at a dose of 400 mg/day (BSA=1.11-1.50 m2) or 300 mg/day (BSA=0.81-1.10 m2) or 200 mg/day (BSA=0.51-0.80 m2) or 100 mg/day (BSA=0.43-0.50 m2).

Alectinib will be administered orally BID (twice a day) with food at a dosage of 600 mg (four 150-mg capsules).

Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg for participants aged \>/=18 years, and 15 mg/kg (maximum 1200 mg) for participants aged \<18 years on Day 1 of each 21-day cycle.

For participants 12-17 years of age, ipatasertib will be administered at the starting dose of 200 mg for participants \< 35 kg, 300 mg for participants \>/= 35 and \< 45 kg, 400 mg for those \>/= 45 kg orally QD, beginning of Cycle 1, on Days 1-21 of each 28-day cycle until the participant experiences disease progression, intolerable toxicity, or withdraws consent.

Trastuzumab emtansine will be administered at 3.6 mg/kg by IV infusion every 21 days until disease progression or unacceptable toxicity. The dosage and administration method also applies for pediatric participants 12-17 years of age.

Trastuzumab emtansine

Idasanutlin will be administered at 250 mg QD (daily) PO for Days 1-5 of each 28-day cycle. Idasanutlin may be given without regard to meals and water can be given as often as necessary or desired. The daily doses should be administered 10-14 hours apart.

Note: Cohort G has been closed for enrollment.

Idasanutlin

GDC-077 will be administered QD at a starting dose of 9 mg PO in repeated 28-day cycles. The dosage and administration method also applies for pediatric participants 12-17 years of age.

Belvarafenib will be administered at a dose 400 mg (PO) BID with adequate water (more than 200 mL). One cycle consists of 28 days. Administration of belvarafenib should occur BID on every day of each 28-day cycle.

Pralsetinib will be self-administered by participants orally at home (except on clinic days) on a continuous daily dosing regimen at a dose of 400 mg/day (four 100-mg capsules per day) for adult and pediatric patients ≥ 12 and \< 18 years of age. A treatment cycle consists of 4 weeks (28 days).

GDC-6036 will be self-administered by patients orally at home (except on clinic days) on a continuous daily dosing regimen for both adult and pediatric patients. A treatment cycle consists of 3 weeks (21 days).

GDC-6036

Camonsertib will be self-administered by patients orally at home (except on clinic days). A treatment cycle consists of 3 weeks and will be given on days 1-3 and days 8-10 of every 21-day cycle.

Camonsertib

Reference Study ID Number: BO41932 https://forpatients.roche.com/

TAPISTRY is a Phase II, global, multicenter, open-label, multi-cohort study designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or in rational, specified combinations in participants with unresectable, locally advanced or metastatic solid tumors determined to harbor specific oncogenic genomic alterations or who are tumor mutational burden (TMB)-high as identified by a validated next-generation sequencing (NGS) assay. Participants with solid tumors will be treated with a drug or drug regimen tailored to their NGS assay results at screening. Participants will be assigned to the appropriate cohort based on their genetic alteration(s). Treatment will be assigned on the basis of relevant oncogenotype, will have cohort-specific inclusion/exclusion criteria, and, unless otherwise specified, will continue until disease progression, loss of clinical benefit, unacceptable toxicity, participant or physician decision to discontinue, or death, whichever occurs first.

Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study

Tumor-Agnostic Precision Immunooncology and Somatic Targeting Rational for You (TAPISTRY) Phase II Platform Trial

Confirmed objective response indicates \>/= 4 weeks after initial documentation of response

The EORTC QLQ-C30 is a validated, reliable self-report measure. It consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), eight symptom scales (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea) and global health/quality of life, with a recall period of the previous week. Scale scores can be obtained for the multi-item scales using rating scales of 4 or 7 points.

The EORTC Item library includes stand-alone symptoms scales and an overall assessment of treatment bother to provide additional information not currently captured in the EORTC QLQ-C30. The scales use the same rating scale and recall period of previous week as the symptom scales in the EORTC QLQ-C30.

Adverse event severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5 (NCI CTCAE v5.0.)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Evaluate the Safety and Activity of Belvarafenib as a Single Agent and in Combination With Either Cobimetinib or Cobimetinib Plus Nivolumab in Patients With NRAS-mutant Advanced Melanoma.	NCT04835805	Melanoma	Belvarafenib Cobimetinib Nivolumab	18 Years -	Genentech, Inc.
HM95573 in Combination With Either Cobimetinib or Cetuximab in Patients With Locally Advanced or Metastatic Solid Tumors	NCT03284502	Locally Advance... Metastatic Soli...	HM95573, cobime... HM95573, cetuxi... HM95573, cobime... HM95573, cetuxi...	19 Years -	Hanmi Pharmaceutical Company Limited
Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study	NCT04589845	Solid Tumors	Entrectinib Entrectinib Alectinib Atezolizumab Ipatasertib Trastuzumab emt... Idasanutlin Inavolisib Belvarafenib Pralsetinib GDC-6036 Camonsertib	-	Hoffmann-La Roche
Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study	NCT04589845	Solid Tumors	Entrectinib Entrectinib Alectinib Atezolizumab Ipatasertib Trastuzumab emt... Idasanutlin Inavolisib Belvarafenib Pralsetinib GDC-6036 Camonsertib	-	Hoffmann-La Roche

Spots Global Cancer Trial Database for belvarafenib

Every month we try and update this database with for belvarafenib cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.