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Monoclonal Antibodies

Ramucirumab for Transitional Cell Carcinoma

Phase 1
Waitlist Available
Research Sponsored by Eli Lilly and Company
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 baseline to date of cr or pr (estimated up 24 months)
Awards & highlights

Study Summary

This trial is testing a combination of drugs to treat various types of cancer. The goal is to see if it is safe and effective.

Eligible Conditions
  • Transitional Cell Carcinoma
  • Biliary Tract Cancer
  • Non-Small Cell Lung Cancer
  • Stomach Cancer
  • Gastroesophageal Junction Adenocarcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to date of cr or pr (estimated up 24 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to date of cr or pr (estimated up 24 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
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
Secondary outcome measures
Duration of Response (DoR)
Overall Survival (OS)
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab
+4 more

Side effects data

From 2016 Phase 3 trial • 1253 Patients • NCT01168973
46%
Fatigue
36%
Neutropenia
32%
Diarrhoea
30%
Decreased appetite
27%
Nausea
26%
Alopecia
24%
Dyspnoea
23%
Stomatitis
22%
Cough
22%
Anaemia
19%
Epistaxis
18%
Neutrophil count decreased
17%
Oedema peripheral
17%
Constipation
16%
Mucosal inflammation
16%
Pyrexia
14%
Lacrimation increased
14%
Vomiting
14%
Febrile neutropenia
13%
Myalgia
13%
Leukopenia
12%
Peripheral sensory neuropathy
12%
Back pain
11%
Dysgeusia
11%
Hypertension
11%
Insomnia
11%
Headache
11%
Arthralgia
11%
Asthenia
11%
Weight decreased
9%
Abdominal pain
9%
White blood cell count decreased
8%
Oropharyngeal pain
8%
Pain in extremity
8%
Thrombocytopenia
7%
Rash
7%
Dizziness
7%
Nail discolouration
6%
Dehydration
6%
Pain
6%
Dyspepsia
6%
Haemoptysis
6%
Paraesthesia
6%
Dysphonia
6%
Productive cough
6%
Hyperglycaemia
6%
Pneumonia
6%
Platelet count decreased
5%
Bone pain
1%
Chronic obstructive pulmonary disease
1%
Hyponatraemia
1%
Metastatic pain
1%
Lobar pneumonia
1%
Pleural effusion
1%
Pneumothorax
1%
Pulmonary embolism
1%
Pulmonary haemorrhage
1%
Syncope
1%
Confusional state
1%
Death
1%
Atrial fibrillation
1%
General physical health deterioration
1%
Renal failure acute
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ramucirumab and Docetaxel
Placebo and Docetaxel

Trial Design

9Treatment groups
Experimental Treatment
Group I: Ramucirumab + Pembrolizumab (Phase 1b Cohort E)Experimental Treatment2 Interventions
NSCLC: Ramucirumab given IV on day 1 in combination with pembrolizumab given IV on day 1 of a 21 day cycle.
Group II: Ramucirumab + Pembrolizumab (Phase 1b Cohort C)Experimental Treatment2 Interventions
NSCLC: Ramucirumab given IV on day 1 in combination with pembrolizumab given IV on day 1 of a 21 day cycle.
Group III: Ramucirumab + Pembrolizumab (Phase 1b Cohort B)Experimental Treatment2 Interventions
Gastric-GEJ: Ramucirumab given IV on day 1 in combination with pembrolizumab given IV on day 1 of a 21 day cycle.
Group IV: Ramucirumab + Pembrolizumab (Phase 1b Cohort A2)Experimental Treatment2 Interventions
Gastric-GEJ (first line only): Ramucirumab given IV on day 1 and 8 in combination with pembrolizumab given IV on day 1 of a 21 day cycle.
Group V: Ramucirumab + Pembrolizumab (Phase 1b Cohort A1)Experimental Treatment2 Interventions
BTC: Ramucirumab given IV on day 1 and 8 in combination with pembrolizumab given IV on day 1 of a 21 day cycle.
Group VI: Ramucirumab + Pembrolizumab (Phase 1b Cohort A)Experimental Treatment2 Interventions
Gastric-GEJ: Ramucirumab given IV on day 1 and 8 in combination with pembrolizumab given IV on day 1 of a 21 day cycle.
Group VII: Ramucirumab + Pembrolizumab (Phase 1a Schedule 2)Experimental Treatment2 Interventions
Gastric, NSCLC, Urothelial: Ramucirumab given IV on day 1 in combination with pembrolizumab given IV on day 1 of a 21 day cycle.
Group VIII: Ramucirumab + Pembrolizumab (Phase 1a Schedule 1)Experimental Treatment2 Interventions
Gastric-GEJ, BTC: Ramucirumab given intravenously (IV) on day 1 and 8 in combination with pembrolizumab given IV on day 1 of a 21 day cycle.
Group IX: Experimental: Ramucirumab + Pembrolizumab (Phase 1b Cohort D)Experimental Treatment2 Interventions
Urothelial: Ramucirumab given IV on day 1 in combination with pembrolizumab given IV on day 1 of a 21 day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ramucirumab
2017
Completed Phase 3
~5050
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,618 Previous Clinical Trials
3,201,262 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,888 Previous Clinical Trials
5,054,706 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,347 Previous Clinical Trials
405,456 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 Study of Ramucirumab Plus Pembrolizumab in Participants With Gastric or GEJ Adenocarcinoma, NSCLC, Transitional Cell Carcinoma of the Urothelium, or Biliary Tract Cancer
2015. "A Study of Ramucirumab Plus Pembrolizumab in Participants With Gastric or GEJ Adenocarcinoma, NSCLC, Transitional Cell Carcinoma of the Urothelium, or Biliary Tract Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02443324.
~31 spots leftby Apr 2025
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