Ipilimumab for Clear Cell Renal Cell Carcinoma

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Clear Cell Renal Cell Carcinoma+6 MoreIpilimumab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new combination treatment for patients with untreated renal cell carcinoma. The usual treatment is immunotherapy with ipilimumab and nivolumab, followed by nivolumab alone. The new treatment adds cabozantinib to nivolumab after initial treatment with ipilimumab and nivolumab. It is not yet known if this new combination treatment is better than the usual treatment.

Eligible Conditions
  • Clear Cell Renal Cell Carcinoma
  • Metastatic Cancer in the Abdominal Organs
  • Metastatic Lymph Node Cancer
  • Sarcomatoid Renal Cell Carcinoma
  • Soft Tissue Sarcoma
  • Bone Metastasis
  • Stage IV Renal Cell Carcinoma

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Up to 5 years

Month 12
Complete response (CR) (randomized patients)
Year 5
Progression-free survival (PFS)
Year 5
Overall survival (OS)
Up to 5 years
Incidence of adverse events
Objective response
Proportion of patients who discontinue protocol-directed treatment prior to 1 year from date of study registration

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

10 MG/KG Ipilimumab + Paclitaxel/ Carbop
38%Alopecia
36%Anaemia
32%Nausea
31%Decreased appetite
31%Diarrhoea
30%Fatigue
25%Constipation
23%Neutropenia
20%Dyspnoea
19%Pyrexia
19%Vomiting
18%Rash
17%Cough
17%Asthenia
16%Arthralgia
16%Pruritus
16%Thrombocytopenia
15%Peripheral sensory neuropathy
14%Myalgia
13%Neuropathy peripheral
13%Insomnia
11%Hypokalaemia
10%Platelet count decreased
9%Pain in extremity
9%Leukopenia
9%Weight decreased
8%Hyponatraemia
8%Pneumonia
8%Alanine aminotransferase increased
8%Haemoglobin decreased
7%Malignant neoplasm progression
7%Back pain
7%Neutrophil count decreased
7%Aspartate aminotransferase increased
7%Dizziness
7%Bone pain
7%Haemoptysis
6%Hypomagnesaemia
6%Stomatitis
6%Headache
5%Abdominal pain
5%Oedema peripheral
5%Chest pain
5%Abdominal pain upper
5%White blood cell count decreased
5%Dehydration
4%Musculoskeletal pain
4%Febrile neutropenia
4%Paraesthesia
3%Colitis
2%Lung infection
2%Pulmonary embolism
2%Death
2%Mucosal inflammation
1%Cardio-respiratory arrest
1%Chronic obstructive pulmonary disease
1%Pulmonary haemorrhage
1%Pneumothorax
1%Interstitial lung disease
1%Urinary tract infection
1%Confusional state
1%Drug hypersensitivity
1%Cerebrovascular accident
1%Lung abscess
1%Multi-organ failure
1%Blood creatinine increased
1%Metastases to central nervous system
1%Atrial fibrillation
1%Disease progression
1%Renal failure
1%Liver function test abnormal
1%Lower respiratory tract infection
1%Lung neoplasm malignant
1%Pain
1%Acute kidney injury
1%Hypersensitivity
1%General physical health deterioration
1%Intestinal perforation
1%Infection
1%Pneumonitis
1%Respiratory failure
1%Syncope
1%Hyperglycaemia
1%Sudden death
1%Sepsis
This histogram enumerates side effects from a completed 2017 Phase 3 trial (NCT01285609) in the 10 MG/KG Ipilimumab + Paclitaxel/ Carbop ARM group. Side effects include: Alopecia with 38%, Anaemia with 36%, Nausea with 32%, Decreased appetite with 31%, Diarrhoea with 31%.

Trial Design

2 Treatment Groups

Arm A (nivolumab)
1 of 2
Arm B (nivolumab, cabozantinib)
1 of 2

Active Control

Experimental Treatment

1046 Total Participants · 2 Treatment Groups

Primary Treatment: Ipilimumab · No Placebo Group · Phase 3

Arm B (nivolumab, cabozantinib)Experimental Group · 5 Interventions: Ipilimumab, Quality-of-Life Assessment, Cabozantinib, Nivolumab, Questionnaire Administration · Intervention Types: Biological, Other, Drug, Biological, Other
Arm A (nivolumab)ActiveComparator Group · 4 Interventions: Ipilimumab, Quality-of-Life Assessment, Nivolumab, Questionnaire Administration · Intervention Types: Biological, Other, Biological, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
FDA approved
Cabozantinib
FDA approved
Nivolumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,073 Previous Clinical Trials
41,137,862 Total Patients Enrolled
Tian ZhangPrincipal InvestigatorAlliance for Clinical Trials in Oncology

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have metastatic disease, including visceral, lymph node, other soft tissue and bone, measurable per RECIST 1.
You have a disease that is measurable by the protocol.
You have a CNS disease, if stable and not otherwise causing symptoms or needing active treatment.
You have a Karnofsky performance status of 70% or higher.
You have received prior treatment with a drug or antibody specifically targeting T-cell co-stimulation or checkpoint pathways.