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Checkpoint Inhibitor

Ipilimumab for Soft Tissue Sarcoma

Phase 2
Waitlist Available
Led By Kristen Ganjoo, MD
Research Sponsored by Kristen Ganjoo
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 24 months
Awards & highlights

Study Summary

This trial is testing a combination of immunotherapy drugs with cryotherapy in people with metastatic or locally advanced soft tissue sarcoma. Researchers want to learn if the treatment is safe and effective, and how it works in this type of cancer.

Eligible Conditions
  • Soft Tissue Sarcoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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
Clinical Response
Secondary outcome measures
Immune-related Clinical Response (irRECIST) Rate
Progression-free Survival (PFS)
Related Adverse Events (Toxicity)

Side effects data

From 2017 Phase 3 trial • 1289 Patients • NCT01285609
38%
Alopecia
36%
Anaemia
32%
Nausea
31%
Decreased appetite
31%
Diarrhoea
30%
Fatigue
25%
Constipation
23%
Neutropenia
20%
Dyspnoea
19%
Vomiting
19%
Pyrexia
18%
Rash
17%
Asthenia
17%
Cough
16%
Pruritus
16%
Thrombocytopenia
16%
Arthralgia
15%
Peripheral sensory neuropathy
14%
Myalgia
13%
Insomnia
13%
Neuropathy peripheral
11%
Hypokalaemia
10%
Platelet count decreased
9%
Pain in extremity
9%
Weight decreased
9%
Leukopenia
8%
Alanine aminotransferase increased
8%
Hyponatraemia
8%
Pneumonia
8%
Haemoglobin decreased
7%
Neutrophil count decreased
7%
Dizziness
7%
Malignant neoplasm progression
7%
Aspartate aminotransferase increased
7%
Bone pain
7%
Haemoptysis
7%
Back pain
6%
Headache
6%
Hypomagnesaemia
6%
Stomatitis
5%
Abdominal pain upper
5%
Oedema peripheral
5%
White blood cell count decreased
5%
Chest pain
5%
Dehydration
5%
Abdominal pain
4%
Febrile neutropenia
4%
Paraesthesia
4%
Musculoskeletal pain
3%
Colitis
2%
Death
2%
Lung infection
2%
Pulmonary embolism
2%
Mucosal inflammation
1%
Lung neoplasm malignant
1%
Multi-organ failure
1%
Cerebrovascular accident
1%
Lung abscess
1%
General physical health deterioration
1%
Interstitial lung disease
1%
Liver function test abnormal
1%
Sudden death
1%
Chronic obstructive pulmonary disease
1%
Metastases to central nervous system
1%
Blood creatinine increased
1%
Atrial fibrillation
1%
Cardio-respiratory arrest
1%
Confusional state
1%
Intestinal perforation
1%
Pulmonary haemorrhage
1%
Drug hypersensitivity
1%
Infection
1%
Pneumothorax
1%
Renal failure
1%
Lower respiratory tract infection
1%
Pain
1%
Respiratory failure
1%
Syncope
1%
Hyperglycaemia
1%
Sepsis
1%
Acute kidney injury
1%
Hypersensitivity
1%
Urinary tract infection
1%
Disease progression
1%
Pneumonitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
10 MG/KG Ipilimumab + Paclitaxel/ Carbop
Placebo + Paclitaxel/ Carboplatin

Trial Design

1Treatment groups
Experimental Treatment
Group I: Ipilimumab/nivolumab + cryotherapyExperimental Treatment3 Interventions
1 mg/kg with nivolumab 3 mg/kg every 3 weeks x 4 doses. (One cycle of treatment is 3 weeks). Cryotherapy (cryoablation) will be performed between investigational agent treatment Cycles 1 and 2
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cryoablation
2016
Completed Phase 2
~1040
Ipilimumab
2014
Completed Phase 3
~2620
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbIndustry Sponsor
2,641 Previous Clinical Trials
4,130,034 Total Patients Enrolled
Kristen GanjooLead Sponsor
2 Previous Clinical Trials
50 Total Patients Enrolled
Kristen Ganjoo, MDPrincipal InvestigatorStanford University
4 Previous Clinical Trials
196 Total Patients Enrolled

Frequently Asked Questions

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

If so, could you please share the findings of other scientific investigations into Ipilimumab?

"At the moment, there are 796 clinical trials being conducted that are studying Ipilimumab. 86 of those trials are still in Phase 3. Even though a majority of the studies for Ipilimumab originate from Pittsburgh, Pennsylvania, 43299 different locations are running these sorts of investigations."

Answered by AI

How many people are enrolled in the clinical trial?

"As of 9/12/2022, this particular clinical trial is no longer recruiting patients. However, there are 460 other studies for soft tissue sarcoma (sts) and 796 trials for Ipilimumab that are currently looking for participants."

Answered by AI

What are we looking to learn from this research?

"This clinical trial will aim to assess Clinical Response over the course of 16 weeks. Additionally, researchers will also be looking at secondary outcomes such as irRECIST Rate and Progression-free survival. Lastly, they will also be monitoring for any related adverse events that may occur during the trial."

Answered by AI

Are there any spots left in this trial for new participants?

"This study is no longer enrolling patients. The posting for this research was created on October 1st, 2019 and edited September 12th, 2022. For those still searching, there are 460 other clinical trials related to soft tissue sarcoma (sts) and 796 studies utilizing Ipilimumab recruiting patients at present."

Answered by AI

Does Ipilimumab carry any serious risks for patients?

"While there is some data indicating that ipilimumab is safe, as this is only a Phase 2 trial, it received a score of 2."

Answered by AI

Ipilimumab is most commonly associated with which medical condition?

"Ipilimumab can be used to effectively treat patients that have undergone anti-angiogenic therapy, as well as those with malignant neoplasms and unresectable melanoma."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Ipilimumab + Nivolumab + Cryotherapy in Metastatic or Locally Advanced Soft Tissue Sarcoma
Kristen Ganjoo 2019. "Ipilimumab + Nivolumab + Cryotherapy in Metastatic or Locally Advanced Soft Tissue Sarcoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04118166.
~5 spots leftby Apr 2025
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