Durvalumab for Refractory Colorectal Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Refractory Colorectal Cancer+24 MoreDurvalumab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new combination therapy for pancreatic, lung, and colon cancers that have spread and become resistant to treatment.

Eligible Conditions
  • Refractory Colorectal Cancer
  • Stage III Colorectal Cancer
  • Stage IV Pancreatic Cancer
  • Stage IVC Colorectal Cancer
  • Non-Small Cell Lung Cancer
  • Stage III Pancreatic Cancer
  • Stage IV Lung Cancer
  • Stage IIIA Colorectal Cancer
  • Lynch Syndrome
  • Stage IIIB Colorectal Cancer
  • Stage IV Colorectal Cancer
  • Stage IVB Lung Cancer
  • Colorectal Cancer
  • Stage IVA Lung Cancer
  • Stage IVB Colorectal Cancer
  • Stage II Pancreatic Cancer
  • Stage III Lung Cancer
  • Stage IIIB Lung Cancer
  • Stage IVA Colorectal Cancer
  • Stage IIIA Lung Cancer
  • Pancreatic Cancer (Refractory)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

10 Primary · 6 Secondary · Reporting Duration: Up to 4 years

At 4 months
Disease control
Year 4
PD-L1 protein levels in the membrane of circulating tumor cells
Radiomic measurements
Year 4
Progression free survival
Year 4
Overall survival
Year 4
Duration of response according to RECIST version 1.1 criteria
Up to 4 years
Best overall response (including CR, PR, SD, and progressive disease [PD], according to RECIST version 1.1 criteria)
Characterization of immune infiltrates
Incidence of adverse events (AEs), serious AEs
Incidence of treatment-emergent AEs (TEAEs), SAEs and death(s)
Objective response
PD-L1 expression
Phosphorylated or total STAT3 expression levels
Physical Examinations
Physiological parameters
Physiological parameters (Laboratory evaluations)
Quantification and characterization of CD8 staining pattern

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

Treatment (danvatirsen, durvalumab)
1 of 1

Experimental Treatment

53 Total Participants · 1 Treatment Group

Primary Treatment: Durvalumab · No Placebo Group · Phase 2

Treatment (danvatirsen, durvalumab)Experimental Group · 2 Interventions: Danvatirsen, Durvalumab · Intervention Types: Drug, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Danvatirsen
Not yet FDA approved
Durvalumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 4 years

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,093 Previous Clinical Trials
41,143,267 Total Patients Enrolled
1 Trials studying Refractory Colorectal Cancer
40 Patients Enrolled for Refractory Colorectal Cancer
AstraZenecaIndustry Sponsor
3,994 Previous Clinical Trials
247,422,524 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,808 Previous Clinical Trials
1,790,438 Total Patients Enrolled
David S HongPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
184 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a histological confirmation of pancreatic cancer, mismatch deficient colorectal cancer, or non-small cell lung cancer (NSCLC) that is refractory to standard therapy or for which no standard of care regimen currently exists.
You have a PS score of 0 or 1.
Blood transfusions intended to elevate any parameters below solely for the intent of meeting study eligibility are not permitted.
You have a platelet count > = 100 000 per microliter.