Sintilimab for Cancer of Unknown Primary Site

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
M D Anderson Cancer Center, Houston, TX
Cancer of Unknown Primary Site+1 More
Sintilimab - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating the efficacy and safety of sintilimab in subjects with CUP.

See full description

Eligible Conditions

  • Cancer of Unknown Primary Site

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Cancer of Unknown Primary Site

Study Objectives

This trial is evaluating whether Sintilimab will improve 1 primary outcome and 6 secondary outcomes in patients with Cancer of Unknown Primary Site. Measurement will happen over the course of Within 4 cycles of treatment (1 cycles equals 28 days).

Year 1
Number of participants with Treatment-Emergent Adverse Events [Safety]
Year 2
Duration of response (DOR)
Year 2
Overall survival (OS)
Year 2
Progression-free survival (PFS)
Up to 2 years
Disease control rate (DCR)
Quality of Life (QOL) Questionnaire
Day 28
Objective response rate (ORR) [Efficacy]

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Cancer of Unknown Primary Site

Side Effects for

Sintilimab (IBI308)
Lymphocyte count decreased
61%
White blood cell count decreased
50%
Pyrexia
46%
Haemoglobin decreased
32%
Hypothyroidism
32%
Blood thyroid stimulating hormone increased
29%
Blood glucose increased
25%
Upper respiratory tract infection
25%
Blood alkaline phosphatase increased
21%
Blood lactate dehydrogenase increased
21%
Platelet count decreased
21%
Urinary tract infection
18%
Blood bilirubin increased
18%
Blood albumin decreased
18%
Lipase increased
18%
Aspartate aminotransferase increased
18%
Sinusitis
18%
Thyroxine free decreased
18%
Globulins increased
18%
Protein urine present
14%
Rash
14%
Thyroxine increased
14%
Alanine aminotransferase increased
11%
Anaemia
11%
Ventricular extrasystoles
11%
Neutrophil count decreased
11%
Gamma-glutamyltransferase increased
7%
Urine ketone body present
7%
Pneumonia
7%
Respiratory tract infection
7%
Diabetes mellitus
7%
Pharyngitis
7%
C-reactive protein increased
7%
Electrolyte imbalance
7%
Nasal obstruction
7%
Protein total decreased
7%
Globulins decreased
7%
Mouth ulceration
7%
Electrocardiogram abnormal
7%
Gastritis
7%
Enterovirus infection
7%
Constipation
7%
Face oedema
7%
Gingivitis
7%
Red blood cells urine positive
7%
Weight decreased
7%
Lymphadenitis
7%
Pain
7%
Autoimmune thyroiditis
7%
Myocardial ischaemia
7%
Haemoglobin urine present
7%
Thyroid function test abnormal
7%
Headache
7%
Pruritus
7%
Hypokalaemia
7%
Nephrolithiasis
7%
Cough
7%
Myalgia
7%
Oropharyngeal pain
7%
Tri-iodothyronine free decreased
7%
Hypoproteinaemia
7%
Gastrointestinal haemorrhage
4%
Localised infection
4%
Pancreatitis acute
4%
Disease progression
4%
Anaphylactic shock
4%
Diabetic ketoacidosis
4%
Intervertebral disc disorder
4%
This histogram enumerates side effects from a completed 2020 Phase 2 trial (NCT03228836) in the Sintilimab (IBI308) ARM group. Side effects include: Lymphocyte count decreased with 61%, White blood cell count decreased with 50%, Pyrexia with 46%, Haemoglobin decreased with 32%, Hypothyroidism with 32%.

Trial Design

1 Treatment Group

Treatment (sintilimab)
1 of 1
Experimental Treatment

This trial requires 45 total participants across 1 different treatment group

This trial involves a single treatment. Sintilimab is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Treatment (sintilimab)
Drug
The study drug is sintilimab. The first dose of study treatment should start on Day 1 of Cycle 1. For the rest of the treatment cycles, the study treatment can be administered 3 day before or 3 days after the scheduled day of administration. Treatment can be delayed for up to 1 week if the administration day is on a holiday or if the subject is otherwise unavailable.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sintilimab
Not yet FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 2 years for reporting.

Closest Location

M D Anderson Cancer Center - Houston, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Cancer of Unknown Primary Site or the other condition listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Has an ECOG PS of 0 - 2.
Must be unsuitable for definitive treatment, such as definitive chemoradiotherapy and/or surgery. For subjects who have received (neo)adjuvant or definitive chemotherapy/chemoradiotherapy, time from the completion of last treatment to disease recurrence must be > 3 months.
Is able to provide archival or fresh tissues for correlative analysis with obtainable results.
Has at least one measurable lesion as per RECIST v1.1.
Complete blood count: absolute neutrophil count (ANC) ≥ 1.0 × 109/L, platelet (PLT) count ≥ 75 × 109/L, hemoglobin (HGB) ≥ 9.0 g/dL. Note: Subjects cannot receive blood transfusion, erythropoietin (EPO), or Granulocyte-colony stimulating factor (GSF) within 7 days prior to the blood collection.
Hepatic function: total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN in subjects without hepatic metastasis; TBIL ≤ 1.5 × ULN, ALT and AST ≤ 5 × ULN in subjects with hepatic metastasis.
Exception: Patients with known Gilbert disease: serum bilirubin level ≤ 3 × ULN.
Female: CrCl=((140-age)×weight(kg)×0.85)/(72×serum creatinine(mg/dL))
Has histopathologically confirmed unresectable, locally advanced, recurrent or metastatic CUP. Patients must have undergone standard work-up to attempt to identify the primary tumor prior to enrollment.
Is refractory or intolerant to at least one line of systemic chemotherapy. Patient ineligible for cytotoxic chemotherapy due to contraindications will be eligible.

Patient Q&A Section

Has sintilimab proven to be more effective than a placebo?

"In patients whose disease was refractory to prior therapy, Sintilimab improved PFS over a 7-day cycle compared with placebo. However, there were no significant differences between groups regarding OS." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of sintilimab?

"The most common adverse events (AEs) observed with sintilimab were infusion-related reactions, including skin reactions, fever, and fatigue; however, these were manageable. In general, sintilimab was well tolerated and safe when administered at the recommended dose." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving sintilimab?

"There have been no other clinical trials employing sintilimab. There is evidence for its effectiveness in some patients with metastatic colorectal cancer. However, the trials were small and had flaws such as very short follow-up periods and inconsistent patient selection criteria. Sintilimab should only be considered after careful analysis of all available data." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for unknown primary tumors?

"It is difficult to estimate the survival rate for unknown primary tumors because the exact cause of death cannot be determined. A retrospective cohort design can help to get a rough estimation of this number. Estimates based on Medicare data should be used cautiously because of possible referral bias. Better data collection techniques must be developed before better estimates can be obtained." - Anonymous Online Contributor

Unverified Answer

Does unknown primary tumors run in families?

"The prognostic significance of an unknown primary tumor remains unclear. Results from a recent paper suggest that the presence of an unknown primary tumor is associated with an increased risk of developing a second primary tumor." - Anonymous Online Contributor

Unverified Answer

Is sintilimab typically used in combination with any other treatments?

"The most common use of sintilimab was in conjunction with systemic therapies. More than two thirds of patients receiving sintilimab had been previously treated. This suggests that patients who have been previously treated with anti-CD20 therapies might not benefit from the addition of sintilimab." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of unknown primary tumors?

"The majority (83%) of patients with an unknown primary tumor had no history of prior malignancy. The most common presenting symptom was painless mass detected during routine screening examination. There were significant differences between patients who developed an unknown primary tumor and those who did not develop one when compared to various patient groups including age, sex, disease duration, BMI, comorbidities, and presence of metastasis. A multivariate analysis revealed that the variables associated with the development of an unknown primary tumor were previous medical history of cancer, male gender, duration of disease over 10 years, and elevated serum LDH level. However, there were no independent predictors for the development of an unknown primary tumor." - Anonymous Online Contributor

Unverified Answer

Is sintilimab safe for people?

"Sintilimab was well tolerated In a recent study population. Only 1 serious adverse event occurred during the course of the study, which did not appear to be related to sintilimab administration." - Anonymous Online Contributor

Unverified Answer

How quickly does unknown primary tumors spread?

"The data suggest that unknown primary tumors may be more aggressive than previously thought. It is uncertain whether this behavior represents metastatic spread or simply reflects the natural history of these tumors." - Anonymous Online Contributor

Unverified Answer

What is unknown primary tumors?

"It is important to identify unknown primary tumors whenever possible because its detection facilitates appropriate treatment. More than 30% of patients with unknown primary tumors have metastases at the time of diagnosis. Metastases occur more often in the liver, lung, bone, kidney, brain, and skin. Most metastases are found during the first 3 years after diagnosis. Survival is poor, but it is higher when the unknown primary tumor is managed aggressively by surgical resection, chemotherapy, or radiation therapy." - Anonymous Online Contributor

Unverified Answer

What is sintilimab?

"Sintilimab is a humanized monoclonal antibody designed to target CD25 on T cells. It was studied in patients with relapsed or refractory Hodgkin's lymphoma and mantle cell lymphoma after initial response to induction chemotherapy. The overall responses were modest. The most common adverse reactions were pneumonitis, myelosuppression, fever, and nausea. There was no apparent relationship between these events and sintilimab levels. Other immune related serious adverse events were infrequent. Sintilimab has not been studied in patients with solid tumor malignancies." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
See if you qualify for this trial
Get access to this novel treatment for Cancer of Unknown Primary Site by sharing your contact details with the study coordinator.