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Monoclonal Antibodies

PDR001 + Trametinib/Dabrafenib for Thyroid Cancer

Phase 2

Waitlist Available

Led By Alan L Ho, MD, PhD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must be able to swallow and retain orally-administered pills without any clinically significant gastrointestinal abnormalities

Patients must have tissue from the primary tumor or metastases available for correlative studies

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial will test whether PDR001, in combination with either trametinib or dabrafenib, can safely and effectively treat thyroid cancer.

Who is the study for?

Adults with certain types of thyroid cancer that have progressed despite previous treatments and can't be cured with surgery or radiation. They must not have a specific mutation (BRAFV600-), should be in good physical condition, able to swallow pills, and not on immunosuppressive drugs. Pregnant women or those who might become pregnant without contraception are excluded.Check my eligibility

What is being tested?

The trial is testing the effectiveness of PDR001 combined with trametinib or dabrafenib for treating advanced thyroid cancer. It aims to determine if this combination therapy is safe and beneficial for patients whose cancer has continued to progress after other treatments.See study design

What are the potential side effects?

Potential side effects may include allergic reactions to monoclonal antibodies, issues from oral medications like gastrointestinal problems, increased risk of infections due to immune system suppression, and possibly others related to heart health as indicated by the eligibility criteria.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can swallow pills without any major stomach or intestine problems.

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I have tissue samples from my cancer available for study.

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My thyroid cancer comes from follicular cells.

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I am older than 18 years.

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My thyroid tumor has a specific BRAF mutation.

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I have had BRAF therapy for my cancer and tolerated it well without severe side effects.

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I have not recently been treated for thyroid cancer.

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My cancer has returned or spread and cannot be cured with surgery or radiation.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My thyroid cancer does not respond to radioactive iodine treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall response rate

Side effects data

From 2019 Phase 1 & 2 trial • 172 Patients • NCT02325739

83%

Aspartate aminotransferase increased

67%

Alanine aminotransferase increased

67%

Diarrhoea

50%

Pyrexia

50%

Abdominal distension

50%

Hyperphosphataemia

33%

Blood bilirubin increased

33%

Oedema peripheral

33%

Anaemia

33%

Abdominal pain

33%

Nausea

33%

Fatigue

33%

Neutrophil count decreased

33%

Pruritus

33%

Rash

17%

Epistaxis

17%

Productive cough

17%

Liver carcinoma ruptured

17%

Tinea cruris

17%

Dysgeusia

17%

Oesophageal varices haemorrhage

17%

Hyperglycaemia

17%

Blood creatinine increased

17%

Hypokalaemia

17%

Vomiting

17%

Rash pustular

17%

Sinusitis

17%

Blood creatine phosphokinase increased

17%

Weight decreased

17%

Gamma-glutamyltransferase increased

17%

Platelet count decreased

17%

Arthralgia

17%

Myalgia

17%

Insomnia

17%

Dyspnoea exertional

17%

Hot flush

17%

Headache

17%

Cough

17%

Pneumonitis

17%

Hyperthyroidism

17%

Blood alkaline phosphatase increased

100%

80%

60%

40%

20%

Study treatment Arm

Phase I: FGF401 120 mg + PDR001 300 mg

All Patients of Combination Dose

Phase I: 120 mg Fed

Phase I: 150 mg Fasted

Phase II: Group 1 - FGF401 120 mg QD

Phase II: Group 2 - FGF401 120 mg QD

Phase II: Group 3 - FGF401 120 mg QD

All Patients of Single Agent FGF401

Phase I: FGF401 80 mg + PDR001 300 mg

All Patients

Phase I: 50 mg Fasted

Phase I: 80 mg Fasted

Phase I: 80 mg Fed

Phase I: 120 mg Fasted

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort B-BRAF MutantExperimental Treatment2 Interventions

Cohort B (BRAF Mutant, resistant to previous BRAF inhibitors): dabrafenib (D) 150 mg twice daily (OR at dose the patient previously tolerated) plus PDR001 400mg IV every 4 weeks.

Group II: Cohort A-BRAF WT tumorsExperimental Treatment2 Interventions

Cohort A (BRAF WT tumors): trametinib (T) 2mg by mouth daily plus PDR001 400mg IV every 4 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dabrafenib

2011

Completed Phase 3

~4120

PDR001

2016

Completed Phase 2

~2700

Trametinib

2014

Completed Phase 2

~1550

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,934 Previous Clinical Trials

588,791 Total Patients Enrolled

Alan L Ho, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

1 Previous Clinical Trials

8 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many medical facilities are conducting this trial?

"Presently, 7 clinical trial sites are up and running. These locations can be found in Basking Ridge, Harrison and Middletown as well as other cities around the nation. To reduce travel time when participating, those interested should select the closest available centre to them."

Answered by AI

Is this experimental trial a pioneering endeavor?

"PDR001 has been under scientific investigation since 2011. Initially, Novartis Pharmaceuticals sponsored the first trial involving 185 participants. Following successful results, PDR001 achieved Phase 1 drug approval. Currently, 118 studies are actively conducted across 1167 cities and 41 countries to further explore this medication's potential benefits."

Answered by AI

Is enrollment for this experiment open to the public?

"Affirmative. Per the information accessible on clinicaltrials.gov, this study is actively in search of candidates to partcipate; it was initially posted on September 2nd 2020 and most recently updated April 29th 2022. The investigation seeks 30 patients from 7 sites across the country."

Answered by AI

What is the extent of patient recruitment for this experiment?

"Correct. According to the details listed on clinicaltrials.gov, this experiment is actively recruiting as of April 29th 2022 after first going live on September 2nd 2020. The trial requires 30 participants from 7 distinct locations."

Answered by AI

Are there any existing records of PDR001 being evaluated in a clinical experiment?

"At present, 118 studies researching the impact of PDR001 are active; 6 are currently in Phase 3. Primarily situated in New york City, there are over 6000 other locations across America running trials for this drug."

Answered by AI

Is PDR001 a safe option for medical treatment?

"As this is a Phase 2 trial, there are some indications of safety for PDR001 but no evidence to demonstrate efficacy. Consequently, it was given a rating of 2 on the scale from 1-3."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PDR001 Combination Therapy for Radioiodine-Refractory Thyroid Cancer

2020. "PDR001 Combination Therapy for Radioiodine-Refractory Thyroid Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04544111.

All > Thyroid Cancer > Thyroid