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Chemotherapy

combination IV gemcitabine and IV carboplatin (AUC2) for Nasopharyngeal Cancer (VANCE Trial)

Phase 3
Waitlist Available
Research Sponsored by Tessa Therapeutics
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 from randomization until death, assessed up to 7 years. survivors and lost to follow-up subjects were censored at the date of last contact. survival follow-up was done every 12 weeks from end of treatment.
Awards & highlights

VANCE Trial Summary

This trial is testing if giving gemcitabine-carboplatin chemotherapy followed by adoptive T-cell therapy would improve clinical outcome for patients with advanced nasopharyngeal carcinoma.

Eligible Conditions
  • Nasopharyngeal Cancer

VANCE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization until death, assessed up to 7 years. survivors and lost to follow-up subjects were censored at the date of last contact. survival follow-up was done every 12 weeks from end of treatment.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization until death, assessed up to 7 years. survivors and lost to follow-up subjects were censored at the date of last contact. survival follow-up was done every 12 weeks from end of treatment. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival (OS) of Subjects With Advanced Nasopharyngeal Carcinoma.
Secondary outcome measures
Best Overall Response (BOR) of Subjects With Advanced Nasopharyngeal Carcinoma.
Clinical Benefit Rate (CBR) of Subjects With Advanced Nasopharyngeal Carcinoma.
Overall Response Rate (ORR) of Subjects With Advanced Nasopharyngeal Carcinoma.
+1 more

Side effects data

From 2022 Phase 3 trial • 330 Patients • NCT02578641
68%
Anemia
39%
Neutropenia
37%
Platelet count decreased
37%
White blood cell count decreased
36%
Neutrophil count decreased
29%
Constipation
29%
Thrombocytopenia
26%
Pyrexia
24%
Leukopenia
22%
Fatigue
18%
Cough
15%
Nausea
14%
Headache
14%
Hyponatraemia
12%
Decreased appetite
11%
Diarrhoea
11%
Dizziness
11%
Back pain
10%
Neck pain
10%
Vomitting
10%
Aspartate aminotransferase increased
10%
Rash
9%
Alanine aminotransferase increased
9%
Insomnia
9%
Pruritis
8%
Epistaxis
7%
Hypokalaemia
6%
Pneumonia
6%
Hyponatremia
6%
Nasopharyngeal cancer
6%
Oropharyngeal pain
6%
Rhinorrhoea
6%
Hypoaesthesia
5%
Tinnitus
3%
febrile neutropenia
2%
Cerebrovascular accident
2%
Septic shock
2%
Seizure
1%
Multiple organ dysfunction syndrome
1%
Upper airway obstruction
1%
Hepatic infection
1%
Peripheral ischemia
1%
Chest pain
1%
Diarrhea
1%
Blood disorder
1%
Presyncope
1%
Orthostatic hypotension
1%
Anaphylactic reaction
1%
Injection site infection
1%
Pulmonary tuberculosis
1%
Nasopharyngeal cancer stage IV
1%
Dysphagia
1%
Gastrointestinal hemorrhage
1%
Rectal hemorrhage
1%
Upper gastrointestinal hemorrhage
1%
Acute pulmonary oedema
1%
Conjunctivitis
1%
Lower respiratory tract infection
1%
Pancytopenia
1%
Death
1%
Sudden death
1%
Musculoskeletal pain
1%
Soft tissue necrosis
1%
Cellulitis
1%
Sinusitis
1%
Urinary tract infection
1%
Anaemia of malignant disease
1%
Antiphospholipid syndrome
1%
Disease progression
1%
Nodule
1%
Vomiting
1%
Gastrointestinal obstruction
1%
Spinal cord compression
1%
Syncope
1%
Vocal cord paralysis
1%
Pleural effusion
1%
Alveolitis allergic
1%
Dyspnea
1%
Mediastinal hematoma
1%
Pneumonia aspiration
1%
Respiratory failure
1%
Hypercalcemia
1%
Hypotension
1%
Spinal compression fracture
1%
Wound secretion
1%
Dermatomyositis
1%
Stevens-Johnson syndrome
1%
Hepatic failure
1%
Mucosal inflammation
1%
Tachycardia
1%
Myocardial infarction
1%
Immune-mediated adverse reaction
1%
Femoral neck fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
Chemo + EBV-CTL
Chemo Only

VANCE Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm AExperimental Treatment2 Interventions
4 cycles* of combination IV Gemcitabine (1000 mg/m2) and IV carboplatin (AUC2) on Days 1, 8, 15 every 28 days, followed sequentially by T-cell immunotherapy (2 cycles) of autologous EBV specific Cytotoxic T cells every 2 weeks, followed by EBV-specific CTL immunotherapy (4 cycles) every 8 weeks after 6 weeks from the second cycle. *Additional 1-2 chemotherapy cycles (up to total 6 chemo cycles) might be given upon discretion of Investigator, if EBV-specific CTL infusions are not available in time for the 1st scheduled infusion. As of 1 May 2020, patients who have not received the first infusion of EBV-specific CTLs, will instead continue to receive a total of 6 cycles combination of Gemcitabine (1000 mg/m2) and carboplatin (AUC2) on Days 1, 8, 15 every 28 days
Group II: Arm BActive Control1 Intervention
6 cycles of combination IV gemcitabine (1000 mg/m2) and IV carboplatin (AUC2) on Days 1, 8, 15 every 28 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
autologous EBV specific Cytotoxic T cells
2014
Completed Phase 3
~330
Gemcitabine
FDA approved

Find a Location

Who is running the clinical trial?

Tessa TherapeuticsLead Sponsor
3 Previous Clinical Trials
133 Total Patients Enrolled
Han Chong TOHStudy ChairNational Cancer Centre Singapore (NCCS)

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
A Phase III Trial Evaluating Chemotherapy and Immunotherapy for Advanced Nasopharyngeal Carcinoma (NPC) Patients
2014. "A Phase III Trial Evaluating Chemotherapy and Immunotherapy for Advanced Nasopharyngeal Carcinoma (NPC) Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02578641.
~31 spots leftby Apr 2025
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