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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
Must not have
Participants with primary neuroendocrine or sarcomatoid histologies. For SCCHN, participants may not have a primary site of nasopharynx or salivary gland
Active bleeding conditions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 4 years
Awards & highlights
No Placebo-Only Group
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has returned or spread and I can't have standard treatment.
Select...
My condition worsened after my last treatment.
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...
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...
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...
I am fully active or restricted in physically strenuous activity but can do light work.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My cancer is not nasopharynx or salivary gland cancer.
Select...
I am currently experiencing active bleeding.
Select...
I have or had another type of cancer besides the one I am seeking treatment for.
Select...
I have pain from my cancer that isn't relieved by treatment.
Select...
I have moderate to severe numbness, tingling, or pain in my hands or feet.
Select...
I have active cancer spread to my brain.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 4 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Confirmed ORR per blinded independent central review (BICR) (Part E)
Confirmed Objective Response Rate (ORR) (Parts A, B, C, D, F, and G)
Secondary study objectives
Cmax
Confirmed and Unconfirmed ORR
Confirmed and Unconfirmed ORR per BICR (Part E)
+11 moreSide effects data
From 2022 Phase 2 trial • 102 Patients • NCT0343839641%
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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 in participants with HNSCC in the first line setting
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 in participants with HNSCC in the first line setting
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 HNSCC 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 in participants with various solid tumors in 1L HNSCC or sqNSCLC
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 HNSCC or sqNSCLC in 2L+
Group VI: Part B: Tisotumab Vedotin - 3Q4W ScheduleExperimental Treatment1 Intervention
Tisotumab Vedotin on Days 1, 8, and 15 of 28-day cycle in participants with various solid tumors in 2L+
Group VII: Part A: Tisotumab Vedotin - Q3W ScheduleExperimental Treatment1 Intervention
Tisotumab Vedotin on Day 1 of every 21-day cycle in participants with various solid tumors in 2L+
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
cisplatin
1997
Completed Phase 3
~3290
tisotumab vedotin
2018
Completed Phase 2
~230
pembrolizumab
2017
Completed Phase 3
~5890
carboplatin
2010
Completed Phase 3
~4790
Find a Location
Who is running the clinical trial?
Seagen Inc.Lead Sponsor
210 Previous Clinical Trials
73,738 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
4,015 Previous Clinical Trials
5,185,641 Total Patients Enrolled
GenmabIndustry Sponsor
71 Previous Clinical Trials
14,229 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have colorectal cancer and have been treated with specific drugs but no more than 3 times for advanced disease.I have taken a tyrosine kinase inhibitor and had no more than 4 treatments for my metastatic condition.I have pancreatic cancer and have had only one treatment for it when it could not be surgically removed.I have squamous cell carcinoma of the head and neck and haven't received systemic therapy for recurrent or metastatic disease.My cancer has a PD-L1 score of 1 or higher, and I can provide a tissue sample.People from outside the European Union do not need to meet a specific requirement called CPS for this part of the study.My cancer has a PD-L1 score of 1 or higher, and I can provide a recent tissue sample.I have lung disease but don't need steroids or long-term oxygen.I have or had another type of cancer besides the one I am seeking treatment for.I have pain from my cancer that isn't relieved by treatment.My condition worsened after my last treatment.My cancer's PD-L1 status is known.I am currently experiencing active bleeding.My cancer has returned or spread and I can't have standard treatment.I have active cancer spread to my brain.I have squamous cell NSCLC and haven't had systemic therapy for metastatic disease or significant lung radiation recently.You have a measurable disease that can be tracked using specific guidelines.I have moderate to severe numbness, tingling, or pain in my hands or feet.I have squamous NSCLC, treated with platinum and CPI, and had no more than 3 treatments for advanced cancer.My cancer is not nasopharynx or salivary gland cancer.I do not have any active eye surface diseases, excluding cataracts.I have previously been treated with specific immune therapy drugs.I have SCCHN and my cancer progressed after platinum or CPI treatment. I've had 3 or fewer treatments for advanced disease.My throat cancer has worsened after treatment, and I've had 1-2 treatments including platinum and PD-(L)1 inhibitors.I am fully active or restricted in physically strenuous activity but can do light work.
Research Study Groups:
This trial has the following groups:- Group 1: Part E: Tisotumab Vedotin - 2Q4W Schedule
- Group 2: Part G: Tisotumab Vedotin Combination Therapy - Q2W Schedule
- Group 3: Part D: Tisotumab Vedotin Combination Therapy - Q3W Schedule
- Group 4: Part F: Tisotumab Vedotin Combination Therapy - Q2W Schedule
- Group 5: Part A: Tisotumab Vedotin - Q3W Schedule
- Group 6: Part B: Tisotumab Vedotin - 3Q4W Schedule
- Group 7: Part C: Tisotumab Vedotin - 2Q4W Schedule
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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