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Checkpoint Inhibitor

Durvalumab for Vaginal Cancer

Phase 1
Waitlist Available
Led By Martin King, MD, PhD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights

Study Summary

This trial is studying how well the combination of durvalumab, tremelimumab, and radiation therapy works in treating patients with gynecologic cancer that has come back or spread to other parts of the body.

Eligible Conditions
  • Vaginal Cancer
  • Vulvar Cancer
  • Gynecological Cancers
  • Ovarian Cancer
  • Endometrial Cancer
  • Cervical Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
This trial's timeline: 3 weeks for screening, Varies for treatment, and one 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
Maximum Tolerated Dose (MTD) of Radiotherapy with durvalumab and tremelimumab
Secondary outcome measures
Abscopal Response Rate
Local Control Rate
Local Response Rate
+4 more

Side effects data

From 2022 Phase 2 trial • 80 Patients • NCT03015129
65%
Fatigue
63%
Abdominal pain
55%
Diarrhea
43%
Pain
40%
Weight loss
35%
Hypertension
30%
Constipation
30%
Anorexia
28%
Nausea
28%
Pruritus
25%
Vomiting
20%
Dyspnea
20%
Urinary tract infection
18%
Rash maculo-papular
15%
Back pain
15%
Cough
15%
Abdominal Pain
15%
Weight gain
15%
Increased Urinary Frequency
13%
Arthralgia
10%
Anxiety
10%
Bladder infection
10%
Dizziness
10%
Nasal congestion
10%
Vaginal discharge
8%
Edema limbs
8%
Fever
8%
Anal pain
8%
Dry skin
8%
Colitis
8%
Thromboembolic event
8%
Dry mouth
8%
Flatulence
8%
Headache
8%
Hot flashes
8%
Myalgia
8%
Urinary tract pain
8%
Urinary frequency
8%
Small intestinal obstruction
5%
Anemia
5%
Ascites
5%
Confusion
5%
Pneumonitis
5%
Sinus bradycardia
5%
Renal and urinary disorders - Other, specify
5%
Adrenal insufficiency
5%
Memory impairment
5%
Vaginal hemorrhage
5%
Hypomagnesemia
5%
Upper respiratory infection
5%
Mucositis oral
5%
Rash acneiform
5%
Urinary urgency
5%
Gastroesophageal reflux disease
5%
Lymphedema
3%
Rectal hemorrhage
3%
Colonic perforation
3%
Generalized muscle weakness
3%
Hyperkalemia
3%
Lethargy
3%
Myocarditis
3%
Fall
3%
Skin infection
3%
Hypothyroidism
3%
Muscle weakness left-sided
3%
Alanine aminotransferase increased
3%
Hyperglycemia
3%
Pleural effusion
3%
Creatinine increased
3%
Rectal pain
3%
Aspartate aminotransferase increased
3%
Dysarthria
3%
Myositis
3%
CPK increased
3%
Pain in extremity
3%
Peripheral sensory neuropathy
3%
Alkaline phosphatase increased
3%
Blood bilirubin increased
3%
Left ventricular systolic dysfunction
3%
Weight Loss
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalubmab
Durvalubmab + Tremelimumab

Trial Design

2Treatment groups
Experimental Treatment
Group I: Phase I Safety Lead-InExperimental Treatment2 Interventions
A modified 3+3 design will be used in this trial Lead-in phase with Durvalumab* and radiation therapy *q4 weeks durvalumab for 13 cycles or until progression
Group II: Phase I Radiation Dose EvaluationExperimental Treatment3 Interventions
Durvalumab Tremelimumab* -- Start radiation dose from safety lead-in (level 0 or level -1) *q4 weeks durvalumab / tremelimumab for 4 cycles and continue durvalumab for 13 cycles or until disease progression
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tremelimumab
2017
Completed Phase 2
~3380
Radiation Therapy
2017
Completed Phase 3
~7250
Durvalumab
2017
Completed Phase 2
~3870

Find a Location

Who is running the clinical trial?

AstraZenecaIndustry Sponsor
4,257 Previous Clinical Trials
288,593,770 Total Patients Enrolled
Dana-Farber Cancer InstituteLead Sponsor
1,078 Previous Clinical Trials
340,856 Total Patients Enrolled
Martin King, MD, PhDPrincipal InvestigatorBrigham and Women's Hospital
3 Previous Clinical Trials
152 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Durvalumab, Tremelimumab + Radiotherapy in Gynecologic Cancer
Martin King, MD, PhD 2018. "Durvalumab, Tremelimumab + Radiotherapy in Gynecologic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03277482.
~2 spots leftby Apr 2025
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