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Alkylating agents

Durvalumab for Cervical Cancer (CALLA Trial)

Phase 3
Waitlist Available
Led By Bradley Monk, M.D
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up estimated to be up to 2.5 years
Awards & highlights

CALLA Trial Summary

This trial is testing whether adding the drug durvalumab to standard chemoradiotherapy improves treatment in women with locally advanced cervical cancer.

Eligible Conditions
  • Cervical Cancer

CALLA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are a woman.

CALLA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~estimated to be up to 2.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and estimated to be up to 2.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free Survival (PFS) Based on the Investigator Assessment According to RECIST 1.1 or Histopathologic Confirmation of Local Tumour Progression
Secondary outcome measures
Complete Response Rate
Duration of Response (DoR) in Patients With Complete Response (CR)
Objective Response Rate (ORR)
+3 more
Other outcome measures
Number of participants with adverse events as assessed by Common Toxicity Criteria for Adverse Events (CTCAE v5.0)
Organum Vasculosum Laminae Terminalis
Organum Vasculosum Laminae Terminalis
+6 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%
Anorexia
30%
Constipation
28%
Nausea
28%
Pruritus
25%
Vomiting
20%
Urinary tract infection
20%
Dyspnea
18%
Rash maculo-papular
15%
Abdominal Pain
15%
Back pain
15%
Weight gain
15%
Cough
15%
Increased Urinary Frequency
13%
Arthralgia
10%
Dizziness
10%
Anxiety
10%
Bladder infection
10%
Nasal congestion
10%
Vaginal discharge
8%
Anal pain
8%
Dry skin
8%
Urinary frequency
8%
Edema limbs
8%
Flatulence
8%
Myalgia
8%
Hot flashes
8%
Thromboembolic event
8%
Fever
8%
Colitis
8%
Dry mouth
8%
Headache
8%
Small intestinal obstruction
8%
Urinary tract pain
5%
Ascites
5%
Lymphedema
5%
Memory impairment
5%
Mucositis oral
5%
Pneumonitis
5%
Confusion
5%
Gastroesophageal reflux disease
5%
Anemia
5%
Urinary urgency
5%
Vaginal hemorrhage
5%
Sinus bradycardia
5%
Hypomagnesemia
5%
Rash acneiform
5%
Renal and urinary disorders - Other, specify
5%
Adrenal insufficiency
5%
Upper respiratory infection
3%
Rectal hemorrhage
3%
CPK increased
3%
Fall
3%
Skin infection
3%
Muscle weakness left-sided
3%
Myositis
3%
Hyperglycemia
3%
Peripheral sensory neuropathy
3%
Colonic perforation
3%
Pain in extremity
3%
Blood bilirubin increased
3%
Rectal pain
3%
Weight Loss
3%
Alanine aminotransferase increased
3%
Aspartate aminotransferase increased
3%
Alkaline phosphatase increased
3%
Creatinine increased
3%
Lethargy
3%
Left ventricular systolic dysfunction
3%
Dysarthria
3%
Hypothyroidism
3%
Myocarditis
3%
Pleural effusion
3%
Hyperkalemia
3%
Generalized muscle weakness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalubmab
Durvalubmab + Tremelimumab

CALLA Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Durvalumab (intravenous infusion)Experimental Treatment4 Interventions
durvalumab + standard of care concurrent chemoradiation therapy(SoC CCRT) followed by durvalumab monotherapy up to 24 months or until PD from the date of randomization
Group II: Placebo (matching placebo for intravenous infusion)Placebo Group3 Interventions
placebo + standard of care concurrent chemoradiation therapy(SoC CCRT)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
external beam radiation therapy (EBRT) + brachytherapy
2019
Completed Phase 3
~770
Carboplatin
2014
Completed Phase 3
~6670
Durvalumab
2017
Completed Phase 2
~3870
Cisplatin
2013
Completed Phase 3
~1940

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,238 Previous Clinical Trials
288,470,651 Total Patients Enrolled
Urban Scheuring, M.D., Ph.D.Study DirectorAstraZeneca
Bradley Monk, M.DPrincipal InvestigatorUniversity of Arizona, Arizona, USA

Frequently Asked Questions

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

Are there any specific inclusion criteria for this clinical trial?

"Women who have been diagnosed with locally advanced cervical cancer and are between 18 and 130 years old may be eligible to participate in this clinical trial. Currently, the research team is looking to enroll approximately 770 individuals."

Answered by AI

What are the conditions that Durvalumab is approved to treat?

"Durvalumab is frequently used as an initial treatment plan. It is also effective in treating advanced thymoma, testicular cancer, carcinoma, and neuroendocrine disorders."

Answered by AI

Are people currently being signed up for this experiment?

"Presently, this study is not enrolling new patients. The trial was initially posted on February 15th, 2019 and was most recently edited on October 13th, 2022. If you are searching for other studies, there are presently 326 trials actively looking for participants with locally advanced cervical cancer and 1437 studies for Durvalumab actively looking for participants."

Answered by AI

Has Durvalumab been cleared by the FDA?

"Durvalumab was rated a 3 on Power's safety scale. This is because it is a Phase 3 trial, meaning that there is not just some data supporting its efficacy, but multiple rounds of data supporting its safety."

Answered by AI

How many different medical facilities are conducting this research today?

"13 sites are currently enrolling patients for this study. To reduce the burden of travel, patients are encouraged to select the location closest to them from the list of participating cities which include La Jolla, Cleveland and Dallas among others."

Answered by AI

Are geriatric patients welcome in this clinical trial?

"This particular study is seeking applicants that are aged 18-130. In comparison, there are 111 trials for those under 18 and 1651 for senior citizens."

Answered by AI

What other scientific papers exist on Durvalumab's effectiveness?

"As of right now, there are 1437 ongoing clinical trials investigating Durvalumab. Of these, 420 are in Phase 3. Additionally, these trials for Durvalumab are being conducted in 72908 different locations, with several in Shanghai, China."

Answered by AI

How many people total will be included in this experiment?

"As of October 13th, 2022, this particular trial is no longer looking for patients. If you check the clinicaltrials.gov website, you will see that there are currently 1437 studies for Durvalumab and 326 studies for patients with locally advanced cervical cancer."

Answered by AI
~127 spots leftby Mar 2025