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Antibody-drug conjugate

tisotumab vedotin for Cervical Cancer

Phase 2
Waitlist Available
Research Sponsored by Seagen Inc.
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 predose of each treatment cycle (cycle 1 to 21) and end of treatment visit (approximately 49 months)
Awards & highlights

Study Summary

This trial is testing a new cancer drug for women who have cervical cancer that has come back or spread.

Eligible Conditions
  • Cervical Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose of each treatment cycle (cycle 1 to 21) and end of treatment visit (approximately 49 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and predose of each treatment cycle (cycle 1 to 21) and end of treatment visit (approximately 49 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants With Confirmed Objective Response (OR) as Assessed by the Independent Review Committee (IRC)
Secondary outcome measures
DOR as Assessed by the Investigator
Duration of Response (DOR) as Assessed by the IRC
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs
+9 more

Side effects data

From 2022 Phase 2 trial • 102 Patients • NCT03438396
41%
Nausea
39%
Alopecia
39%
Epistaxis
35%
Fatigue
33%
Anaemia
31%
Conjunctivitis
25%
Diarrhoea
25%
Dry eye
20%
Constipation
19%
Peripheral sensory neuropathy
18%
Asthenia
18%
Decreased appetite
17%
Vomiting
17%
Arthralgia
17%
Myalgia
15%
Pyrexia
14%
Rash
14%
Pruritus
14%
Weight decreased
13%
Abdominal pain
13%
Pain in extremity
11%
Keratitis
10%
Urinary tract infection
10%
Vaginal haemorrhage
10%
Insomnia
9%
Cough
9%
Haematuria
8%
Dry mouth
8%
Headache
8%
Back pain
8%
Oedema peripheral
7%
Influenza like illness
7%
Blepharitis
7%
Nasopharyngitis
7%
Musculoskeletal pain
6%
Abdominal pain upper
6%
Punctate keratitis
6%
Rhinorrhoea
6%
Hypomagnesaemia
6%
Upper respiratory tract infection
6%
Rash maculo-papular
6%
Hypokalaemia
5%
Dyspnoea
5%
Anxiety
5%
Dysuria
5%
Hot flush
5%
Erythema
5%
Bone pain
4%
Muscle spasms
4%
Ulcerative keratitis
4%
Ocular hyperaemia
4%
Lacrimation increased
4%
Neutropenia
4%
Peripheral sensorimotor neuropathy
4%
Paraesthesia
4%
Dehydration
4%
Depression
4%
Nasal dryness
4%
Dysgeusia
4%
Dizziness
4%
Burning sensation
4%
Hypocalcaemia
4%
Vaginal discharge
4%
Pneumonia
3%
Venous thrombosis limb
3%
Neuropathy peripheral
3%
Dyspepsia
3%
Rectal haemorrhage
3%
Stomatitis
3%
Chills
3%
Pain
3%
Dry skin
3%
Hyperhidrosis
3%
Cystitis
3%
Vision blurred
3%
Meibomianitis
3%
Eye discharge
3%
Entropion
3%
Iron deficiency anaemia
3%
Oropharyngeal pain
3%
Hypoaesthesia
3%
Neutrophil count decreased
3%
Activated partial thromboplastin time prolonged
3%
Pelvic pain
3%
Flank pain
3%
Lymphoedema
3%
Rhinitis
3%
Nasal congestion
3%
Peripheral motor neuropathy
3%
Hyperglycaemia
3%
Hypertransaminasaemia
2%
Hypertension
2%
Ileus
2%
Urinary tract obstruction
2%
Gingival bleeding
2%
Haemorrhoids
2%
Limb discomfort
2%
Cataract
2%
Conjunctival haemorrhage
2%
Dysphonia
2%
Corneal erosion
2%
Conjunctival hyperaemia
2%
Sinus congestion
2%
Pulmonary embolism
2%
Neuralgia
2%
Platelet count decreased
2%
Lymphocyte count decreased
2%
Hypercreatininaemia
2%
Urinary incontinence
2%
Renal failure
2%
Vertigo
2%
Sinus tachycardia
2%
Contusion
2%
Pneumonitis
2%
Polyneuropathy
2%
Septic shock
2%
Gastritis
2%
Haematochezia
2%
Vaginal infection
2%
Blood creatinine increased
2%
Hypothyroidism
2%
Muscular weakness
2%
Hyperuricaemia
2%
Death
2%
Abdominal distension
2%
Trichiasis
2%
International normalised ratio increased
2%
Electrocardiogram QT prolonged
2%
Blood creatine phosphokinase increased
1%
Chest pain
1%
Neutropenic sepsis
1%
Respiratory tract infection
1%
Urosepsis
1%
Intestinal obstruction
1%
Large intestinal obstruction
1%
Non-cardiac chest pain
1%
Acute kidney injury
1%
Cystitis haemorrhagic
1%
Pleural effusion
1%
Foot fracture
1%
Post-traumatic pain
1%
Thoracic vertebral fracture
1%
Fistula discharge
1%
Bladder cancer
1%
Cancer pain
1%
General physical condition abnormal
1%
Ulcerative Keratitis
1%
Anal haemorrhage
1%
Anal incontinence
1%
Dyschezia
1%
Enteritis
1%
Flatulence
1%
Hiatus hernia
1%
Large intestinal haemorrhage
1%
Lower gastrointestinal haemorrhage
1%
Oesophagitis
1%
Retching
1%
Small intestinal stenosis
1%
Subileus
1%
Face oedema
1%
Chest discomfort
1%
Facial pain
1%
Gait disturbance
1%
Infusion site coldness
1%
Localised oedema
1%
Malaise
1%
Mucosal disorder
1%
Nodule
1%
Oedema
1%
Pain of skin
1%
Skin discolouration
1%
Skin hyperpigmentation
1%
Abscess limb
1%
Bronchitis
1%
Catheter site infection
1%
Clostridium difficile colitis
1%
Corona virus infection
1%
Device related infection
1%
Diverticulitis
1%
Folliculitis
1%
Gastroenteritis
1%
Herpes ophthalmic
1%
Herpes zoster oticus
1%
Stenotrophomonas infection
1%
Tooth abscess
1%
Urinary tract infection bacterial
1%
Hypercreatinaemia
1%
Joint stiffness
1%
Musculoskeletal chest pain
1%
Blepharospasm
1%
Chalazion
1%
Conjunctival erosion
1%
Nasal obstruction
1%
Haemoptysis
1%
Ocular hypertension
1%
Noninfective conjunctivitis
1%
Meibomian gland dysfunction
1%
Keratopathy
1%
Eye pruritus
1%
Eye pain
1%
Eye movement disorder
1%
Eye irritation
1%
Eye inflammation
1%
Corneal scar
1%
Corneal bleeding
1%
Leukopenia
1%
Leukocytosis
1%
Sensory loss
1%
Sciatica
1%
Pulmonary oedema
1%
Paranasal sinus discomfort
1%
Paranasal sinus haemorrhage
1%
Hypercalcaemia
1%
Diabetes mellitus
1%
Ejection fraction decreased
1%
C-reactive protein increased
1%
Blood potassium decreased
1%
Alanine aminotransferase increased
1%
White blood cell count decreased
1%
Creatinine renal clearance decreased
1%
Urinary tract disorder
1%
Urinary bladder haemorrhage
1%
Ureteric obstruction
1%
Hydronephrosis
1%
Chromaturia
1%
Bladder outlet obstruction
1%
Metrorrhagia
1%
Genital swelling
1%
Genital prolapse
1%
Cystocele
1%
Acoustic neuroma
1%
Allergy to metals
1%
Hyperthyroidism
1%
Tinnitus
1%
Myocardial infarction
1%
Tumour pain
1%
Deep vein thrombosis
1%
Aortic thrombosis
1%
Urinary tract stoma complication
1%
Thermal burn
1%
Spinal compression fracture
1%
Radiation proctitis
1%
Radiation associated haemorrhage
1%
Procedural pain
1%
Post procedural haemorrhage
1%
Ligament sprain
1%
Conjunctival scar
1%
Conjunctival abrasion
1%
Gastrooesophageal reflux disease
1%
Small intestinal obstruction
1%
Mouth ulceration
1%
Mucosal inflammation
1%
Peripheral swelling
1%
Thirst
1%
Dermatitis acneiform
1%
Dermatitis allergic
1%
Eczema
1%
Rash macular
1%
Groin pain
1%
Hyponatraemia
1%
Thrombocytosis
1%
Thrombocytopenia
1%
Thrombosis
1%
Hypotension
1%
Herpes zoster
1%
Foreign body sensation in eyes
1%
Cellulitis
1%
Infection
1%
Lower respiratory tract infection
1%
Infusion site extravasation
1%
Abdominal discomfort
1%
Abdominal pain lower
1%
Colitis
1%
Duodenogastric reflux
1%
Genital herpes
1%
Gingivitis
1%
Parotitis
1%
Pharyngitis streptococcal
1%
Musculoskeletal discomfort
1%
Neck pain
1%
Osteoarthritis
1%
Amblyopia
1%
Asthenopia
1%
Retinal exudates
1%
Photophobia
1%
Sneezing
1%
Hyperaesthesia
1%
Weight increased
1%
Prothrombin time prolonged
1%
Hypoalbuminaemia
1%
Hypernatraemia
1%
Blood bicarbonate decreased
1%
Blood alkaline phosphatase increased
1%
Aspartate aminotransferase increased
1%
Depressed mood
1%
Vulvovaginal pain
1%
Vaginal ulceration
1%
Vaginal fistula
1%
Rectocele
1%
Hyperbilirubinaemia
1%
Stress cardiomyopathy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tisotumab Vedotin

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single armExperimental Treatment1 Intervention
tisotumab vedotin (IV), 2.0 mg/kg, every 3 weeks (1Q3W)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
tisotumab vedotin
2018
Completed Phase 2
~230

Find a Location

Who is running the clinical trial?

GenmabIndustry Sponsor
56 Previous Clinical Trials
12,130 Total Patients Enrolled
Gynecologic Oncology GroupNETWORK
250 Previous Clinical Trials
70,824 Total Patients Enrolled
European Network of Gynaecological Oncological Trial Groups (ENGOT)OTHER
35 Previous Clinical Trials
16,537 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
A Trial of Tisotumab Vedotin in Cervical Cancer
2018. "A Trial of Tisotumab Vedotin in Cervical Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03438396.
~15 spots leftby Apr 2025
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