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Antibody-Drug Conjugate

Tisotumab Vedotin for Cancer (innovaTV 207 Trial)

Phase 2
Recruiting
Research Sponsored by Seagen Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Relapsed, locally-advanced or metastatic colorectal or pancreatic cancer, sqNSCLC, or SCCHN participants who are not candidates for standard therapy
All participants must have experienced disease progression on or after their most recent systemic therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 4 years
Awards & highlights

innovaTV 207 Trial Summary

This trial will study tisotumab vedotin to find out whether it is an effective treatment for certain solid tumors and what side effects (unwanted effects) may occur. There are four parts to this study.

Who is the study for?
This trial is for patients with certain solid tumors like colorectal, pancreatic, and non-small cell lung cancer who have seen their disease progress after treatment. They must have tried specific therapies depending on the type of cancer and can't be candidates for standard therapy. Participants need a performance status score of 0 or 1, indicating they are fully active or restricted in physically strenuous activity but ambulatory.Check my eligibility
What is being tested?
The study tests tisotumab vedotin alone or combined with pembrolizumab and/or platinum-based chemotherapy (carboplatin or cisplatin) across seven parts with varying schedules. It aims to determine effectiveness against solid tumors and identify potential side effects from these treatments.See study design
What are the potential side effects?
Possible side effects include reactions at the infusion site, fatigue, nausea, hair loss from chemotherapy drugs like carboplatin and cisplatin; immune-related adverse events such as skin rash or inflammation in organs due to pembrolizumab; neuropathy may also occur.

innovaTV 207 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer has returned or spread and I can't have standard treatment.
Select...
My condition worsened after my last treatment.
Select...
I have colorectal cancer and have been treated with specific drugs but no more than 3 times for advanced disease.
Select...
I have squamous NSCLC, treated with platinum and CPI, and had no more than 3 treatments for advanced cancer.
Select...
I have taken a tyrosine kinase inhibitor and had no more than 4 treatments for my metastatic condition.
Select...
I have pancreatic cancer and have had only one treatment for it when it could not be surgically removed.
Select...
I have SCCHN and my cancer progressed after platinum or CPI treatment. I've had 3 or fewer treatments for advanced disease.
Select...
My throat cancer has worsened after treatment, and I've had 1-2 treatments including platinum and PD-(L)1 inhibitors.
Select...
I have squamous cell carcinoma of the head and neck and haven't received systemic therapy for recurrent or metastatic disease.
Select...
I have squamous cell NSCLC and haven't had systemic therapy for metastatic disease or significant lung radiation recently.
Select...
My cancer's PD-L1 status is known.
Select...
My cancer has a PD-L1 score of 1 or higher, and I can provide a tissue sample.
Select...
My cancer has a PD-L1 score of 1 or higher, and I can provide a recent tissue sample.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.

innovaTV 207 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 4 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
Confirmed ORR per blinded independent central review (BICR) (Part E)
Confirmed Objective Response Rate (ORR) (Parts A, B, C, D, F, and G)
Secondary outcome measures
Cmax
Confirmed and Unconfirmed ORR
Confirmed and Unconfirmed ORR per BICR (Part E)
+12 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

innovaTV 207 Trial Design

7Treatment groups
Experimental Treatment
Group I: Part G: Tisotumab Vedotin Combination Therapy - Q2W ScheduleExperimental Treatment3 Interventions
Tisotumab Vedotin + pembrolizumab + carboplatin. Tisotumab Vedotin and carboplatin given on Days 1, 15, and 29 of every 6-week cycle. Pembrolizumab given on Day 1 of every 6-week cycle.
Group II: Part F: Tisotumab Vedotin Combination Therapy - Q2W ScheduleExperimental Treatment2 Interventions
Tisotumab Vedotin + pembrolizumab. Tisotumab Vedotin given on Days 1, 15, and 29 of every 6-week cycle. Pembrolizumab given on Day 1 of every 6-week cycle.
Group III: Part E: Tisotumab Vedotin - 2Q4W ScheduleExperimental Treatment1 Intervention
Tisotumab Vedotin on Days 1 and 15 of every 28-day cycle in participants with SCCHN in the second- or third-line setting
Group IV: Part D: Tisotumab Vedotin Combination Therapy - Q3W ScheduleExperimental Treatment4 Interventions
Tisotumab vedotin + pembrolizumab + (carboplatin or cisplatin). Given on Day 1 of every 21-day cycle.
Group V: Part C: Tisotumab Vedotin - 2Q4W ScheduleExperimental Treatment1 Intervention
Tisotumab Vedotin on Days 1 and 15 of every 28-day cycle in participants with SCCHN or sqNSCLC
Group VI: Part B: Tisotumab Vedotin - 3Q4W ScheduleExperimental Treatment1 Intervention
Tisotumab Vedotin on Days 1, 8, and 15 of 28-day cycle
Group VII: Part A: Tisotumab Vedotin - Q3W ScheduleExperimental Treatment1 Intervention
Tisotumab Vedotin every 3 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
tisotumab vedotin
2018
Completed Phase 2
~230
pembrolizumab
2018
Completed Phase 3
~6240
carboplatin
2010
Completed Phase 3
~4790
cisplatin
1997
Completed Phase 3
~3290

Find a Location

Who is running the clinical trial?

Seagen Inc.Lead Sponsor
206 Previous Clinical Trials
68,647 Total Patients Enrolled
GenmabIndustry Sponsor
56 Previous Clinical Trials
11,540 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,868 Previous Clinical Trials
5,051,296 Total Patients Enrolled

Media Library

Tisotumab Vedotin (Antibody-Drug Conjugate) Clinical Trial Eligibility Overview. Trial Name: NCT03485209 — Phase 2
Squamous Cell Carcinoma Research Study Groups: Part E: Tisotumab Vedotin - 2Q4W Schedule, Part F: Tisotumab Vedotin Combination Therapy - Q2W Schedule, Part G: Tisotumab Vedotin Combination Therapy - Q2W Schedule, Part A: Tisotumab Vedotin - Q3W Schedule, Part B: Tisotumab Vedotin - 3Q4W Schedule, Part C: Tisotumab Vedotin - 2Q4W Schedule, Part D: Tisotumab Vedotin Combination Therapy - Q3W Schedule
Squamous Cell Carcinoma Clinical Trial 2023: Tisotumab Vedotin Highlights & Side Effects. Trial Name: NCT03485209 — Phase 2
Tisotumab Vedotin (Antibody-Drug Conjugate) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03485209 — Phase 2

Frequently Asked Questions

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

Are there any sites conducting this research outside of the United States?

"This trial has many different locations where patients can receive treatment. Some of these sites include University Cancer & Blood Center, LLC in Athens, Joe Arrington Cancer Research and Treatment Center in Lubbock, the University of Virginia in Charlottesville, as well as 21 other centres."

Answered by AI

Are we still looking for patients to participate in this research?

"The trial is recruiting for 532 participants across 21 locations."

Answered by AI

Does tisotumab vedotin have any dangerous side effects?

"While there is some safety data from Phase 2 clinical trials, tisotumab vedotin did not demonstrate efficacy in any of the studies. For this reason, it receives a score of 2."

Answered by AI

Is tisotumab vedotin a new medication?

"tisotumab vedotin was first researched in 2018 at Memorial Sloan Kettering Cancer Center. Since that time, there have been 500 completed studies related to tisotumab vedotin. Now, in the present day, there are 3 medical trials actively recruiting patients with a notable number of these taking place in Athens, Georgia."

Answered by AI

What illness does tisotumab vedotin commonly treat?

"Tisotumab vedotin can be used as a form of pharmacotherapy to treat neoplasm metastasis and monotherapy."

Answered by AI

Is this a new clinical trial?

"As of now, there are 3 ongoing clinical trials for tisotumab vedotin in 160 cities and 26 countries. The first trial was conducted in 2018 by Genmab. Out of the 532 participants, the Phase 2 drug approval stage was completed successfully. In the two years since 2018, 500 more studies have been completed."

Answered by AI

How many people are being signed up for this clinical trial?

"In total, 532 participants who meet the eligibility requirements are necessary for this clinical trial. These individuals can receive treatment at various locations, such as University Cancer & Blood Center, LLC in Athens, Georgia and Joe Arrington Cancer Research and Treatment Center in Lubbock, Texas."

Answered by AI
~110 spots leftby Apr 2025