PDR001 for Poorly Differentiated Thyroid Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Poorly Differentiated Thyroid Cancer+5 MorePDR001 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Poorly Differentiated Thyroid Cancer
  • Hurthle Cell Thyroid Cancer
  • Thyroid Cancer
  • Hurthle Cell Tumor
  • Follicular Thyroid Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 1 year

1 year
Overall response rate

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Phase I: 120 mg Fed
74%Diarrhoea
74%Aspartate aminotransferase increased
58%Alanine aminotransferase increased
32%Nausea
32%Vomiting
26%Blood alkaline phosphatase increased
26%Pruritus
21%Fatigue
21%Abdominal pain
16%Asthenia
11%Decreased appetite
11%Gamma-glutamyltransferase increased
11%Blood creatine phosphokinase increased
11%Anaemia
11%Hyponatraemia
11%Cough
11%Blood bilirubin increased
11%Weight decreased
5%Gastrointestinal haemorrhage
5%Thrombocytopenia
5%Abdominal pain upper
5%Leukopenia
5%Bronchitis
5%Nasopharyngitis
5%Spinal cord compression
5%Toothache
5%Ascites
5%Haemoptysis
5%Angular cheilitis
5%Pyrexia
5%Hyperbilirubinaemia
5%Jaundice cholestatic
5%Rhinitis
5%Bone contusion
5%Blood cholesterol increased
5%Transaminases increased
5%Hyperglycaemia
5%Hypophosphataemia
5%Flank pain
5%Insomnia
5%Female genital tract fistula
5%Varicocele
5%Pneumonitis
5%Rash maculo-papular
5%Upper gastrointestinal haemorrhage
5%Pulmonary embolism
5%Herpes virus infection
5%Hypomagnesaemia
5%Groin pain
5%Musculoskeletal pain
5%Dizziness
5%Depression
5%Coronary artery disease
5%Constipation
5%Animal bite
5%Peripheral swelling
This histogram enumerates side effects from a completed 2019 Phase 1 & 2 trial (NCT02325739) in the Phase I: 120 mg Fed ARM group. Side effects include: Diarrhoea with 74%, Aspartate aminotransferase increased with 74%, Alanine aminotransferase increased with 58%, Nausea with 32%, Vomiting with 32%.

Trial Design

2 Treatment Groups

Cohort A-BRAF WT tumors
1 of 2
Cohort B-BRAF Mutant
1 of 2

Experimental Treatment

30 Total Participants · 2 Treatment Groups

Primary Treatment: PDR001 · No Placebo Group · Phase 2

Cohort A-BRAF WT tumorsExperimental Group · 2 Interventions: PDR001, Trametinib · Intervention Types: Drug, Drug
Cohort B-BRAF MutantExperimental Group · 2 Interventions: PDR001, Dabrafenib · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Spartalizumab
Not yet FDA approved
Dabrafenib
FDA approved
Trametinib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,833 Previous Clinical Trials
588,360 Total Patients Enrolled
Alan L Ho, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
32 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Cohort A: BRAF V600E mutation is not present in the primary tumor.
Cohort A: Cohort A Only: Evidence of progressive disease (e.g
Cohort B: A BRAFV600 mutation is present in a thyroid tumor.
You have recurrent or metastatic disease not amenable to curative surgery or radiation.
You have no symptoms or signs of cancer.
Patients must have documented progression (evidence of tumor growth or appearance of new tumor) on prior BRAF directed therapy (e.g.
You have pathologically or cytologically confirmed differentiated thyroid cancer of follicular origin.