Durvalumab for Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Cancer+1 MoreDurvalumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test how well a combination of two immunotherapy drugs work in treating advanced rare solid tumors.

Eligible Conditions
  • Cancer
  • Rare Diseases

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 1 Secondary · Reporting Duration: 24 months

24 months
Antitumor Activity
Expression of programmed cell death protein 1 (PD-1)
Incidence of Treatment-Emergent and Non Treatment-Emergent Adverse Events [Safety and Tolerability]

Trial Safety

Safety Progress

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

Side Effects for

DUR + R2-CHOP
100%Neutropenia
67%Nausea
67%Constipation
67%Peripheral sensory neuropathy
67%Fatigue
67%Stomatitis
33%Spinal pain
33%Cognitive disorder
33%Leukopenia
33%Dysuria
33%Oral herpes
33%Erythema
33%Blood pressure increased
33%Oedema peripheral
33%Anaemia
33%Dizziness
33%Hypokalaemia
33%Generalised erythema
33%Pulmonary embolism
33%Gastrooesophageal reflux disease
33%Restless legs syndrome
33%Sensory disturbance
33%Hypoacusis
33%Muscle spasms
33%Histiocytic necrotising lymphadenitis
33%Pneumonia
33%Infusion related reaction
33%Diarrhoea
33%Platelet count decreased
33%Rash
33%Febrile neutropenia
This histogram enumerates side effects from a completed 2022 Phase 2 trial (NCT03003520) in the DUR + R2-CHOP ARM group. Side effects include: Neutropenia with 100%, Nausea with 67%, Constipation with 67%, Peripheral sensory neuropathy with 67%, Fatigue with 67%.

Trial Design

1 Treatment Group

Single Arm
1 of 1

Experimental Treatment

100 Total Participants · 1 Treatment Group

Primary Treatment: Durvalumab · No Placebo Group · Phase 2

Single ArmExperimental Group · 2 Interventions: Durvalumab, Tremelimumab · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
FDA approved
Tremelimumab
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months

Who is running the clinical trial?

Prisma Health-UpstateLead Sponsor
74 Previous Clinical Trials
48,017 Total Patients Enrolled
AstraZenecaIndustry Sponsor
3,993 Previous Clinical Trials
247,423,562 Total Patients Enrolled
MedImmune LLCIndustry Sponsor
347 Previous Clinical Trials
793,697 Total Patients Enrolled
William J Edenfield, MDPrincipal InvestigatorPrisma Health-Upstate
1 Previous Clinical Trials
30 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a rare advanced solid malignancy meeting EORTC criteria.
Subjects must have failed or been ineligible to receive standard treatment options if available.
Subjects must be amenable to biopsy of a tumor site or have recent (< 2 years) archival material available.
You have a life expectancy of at least 3 months.