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New treatment option for Solid Tumors
Official title Controlled Cold Exposure Combined With PD-1/PD-L1 Immunotherapy in Solid Tumors (NIVALIS)
ClinicalTrials.gov ID: NCT07538479
What this study is testing
What is Investigator-Selected Standard PD-1/PD-L1 Inhibitor-Based Therapy?
Investigator-Selected Standard PD-1/PD-L1 Inhibitor-Based Therapy is an investigational medicine, being studied as a potential treatment for solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a single-center, prospective, single-arm, open-label phase I exploratory study that plans to enroll 24 participants with solid malignancies. All participants will receive controlled cold exposure in addition to standard PD-1/PD-L1 inhibitor monotherapy or PD-1/PD-L1 inhibitor-based standard combination therapy.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 1\. Age 18-75 years, regardless of sex. 2. Histologically or cytologically confirmed malignant solid tumor. 3. Evaluated by the treating physician or...
- 4\. Applicable settings include neoadjuvant, perioperative, or conversion therapy, as well as unresectable locally advanced, recurrent, or metastatic...
- 5\. At least one evaluable lesion; for patients assessed by RECIST 1.1, at least one measurable lesion is required. Patients planned for surgery may...
- 6\. ECOG performance status 0-1; selected patients with ECOG 2 may be enrolled at the investigator's discretion if considered able to tolerate the...
- 7\. Expected survival ≥3 months. 8. Adequate major organ function, including hematologic, hepatic, renal, and electrolyte parameters acceptable for...
You likely can't join if
- 1\. Participation in another treatment clinical study or receipt of another investigational treatment within 4 weeks before study treatment...
- 2\. Uncontrolled active infection, including but not limited to severe bacterial, viral, or fungal infection, or active tuberculosis.
- 3\. HIV infection; chronic HBV or HCV infection with uncontrolled viral replication or unacceptable liver function.
- 4\. Known severe hypersensitivity to the intended PD-1/PD-L1 inhibitor or its excipients.
- 5\. Active autoimmune disease or a requirement for long-term moderate- to high-dose immunosuppressive therapy; physiological replacement-dose...
- 6\. Prior severe or life-threatening immune-related adverse events during PD-1/PD-L1 inhibitor therapy that have not resolved or are considered...
See the full eligibility criteria
Who can join
- 1\. Age 18-75 years, regardless of sex. 2. Histologically or cytologically confirmed malignant solid tumor. 3. Evaluated by the treating physician or multidisciplinary team (MDT) as currently planned to receive standard...
- 4\. Applicable settings include neoadjuvant, perioperative, or conversion therapy, as well as unresectable locally advanced, recurrent, or metastatic disease planned for systemic therapy.
- 5\. At least one evaluable lesion; for patients assessed by RECIST 1.1, at least one measurable lesion is required. Patients planned for surgery may also be included if adequate preoperative imaging and postoperative...
- 6\. ECOG performance status 0-1; selected patients with ECOG 2 may be enrolled at the investigator's discretion if considered able to tolerate the study procedures.
- 7\. Expected survival ≥3 months. 8. Adequate major organ function, including hematologic, hepatic, renal, and electrolyte parameters acceptable for clinical study participation.
- 9\. Cardiopulmonary function at rest adequate to tolerate the study procedures, without obvious abnormalities indicating intolerance to cold exposure.
- 10\. Toxicities from prior antitumor therapy must have recovered to ≤ Grade 1, except for alopecia or clinically insignificant abnormalities judged by the investigator; for patients previously treated with PD-1/PD-L1...
- 11\. No clear contraindication to cold exposure, and deemed able to tolerate cold exposure combined with immunotherapy by the investigator.
- 12\. Negative pregnancy test for women of childbearing potential; participants of reproductive potential must agree to use effective contraception during the study and for at least 3 months after the last dose.
- 13\. Able to understand the study objectives, procedures, and potential risks, and willing to provide written informed consent.
- 14\. For participants planned for neoadjuvant, perioperative, or conversion therapy, the investigator must confirm that study procedures will not delay planned surgery or other critical treatments.
What rules you out
- 1\. Participation in another treatment clinical study or receipt of another investigational treatment within 4 weeks before study treatment initiation.
- 2\. Uncontrolled active infection, including but not limited to severe bacterial, viral, or fungal infection, or active tuberculosis.
- 3\. HIV infection; chronic HBV or HCV infection with uncontrolled viral replication or unacceptable liver function.
- 4\. Known severe hypersensitivity to the intended PD-1/PD-L1 inhibitor or its excipients.
- 5\. Active autoimmune disease or a requirement for long-term moderate- to high-dose immunosuppressive therapy; physiological replacement-dose steroids may be allowed at the investigator's discretion.
- 6\. Prior severe or life-threatening immune-related adverse events during PD-1/PD-L1 inhibitor therapy that have not resolved or are considered high-risk for re-exposure.
- 7\. Significant cardiovascular disease, including but not limited to unstable angina, severe arrhythmia, NYHA class III-IV heart failure, LVEF \<50%, or myocardial infarction, stroke, or severe thrombotic events within...
- 8\. Severe chronic respiratory disease, especially conditions likely to worsen under cold stimulation, such as severe COPD or severe asthma.
- 9\. Clear contraindications to cold exposure, including prior severe cold-related injury, cold urticaria, cryoglobulinemia, active Raynaud's syndrome, or other diseases judged by the investigator to preclude tolerance...
- 10\. Uncontrolled symptomatic central nervous system metastases. 11. Severe psychiatric illness, cognitive impairment, substance abuse, or alcohol dependence that would interfere with compliance.
- 12\. Pregnancy or breastfeeding. 13. Uncontrolled diabetes, severe malnutrition, marked frailty, or any other condition judged to make the participant unable to tolerate cold exposure or study procedures.
- 14\. Any situation in which study participation may significantly delay standard therapy, planned surgery, or other critical treatment timing.
The study team makes the final eligibility decision.
Where it's taking place
- Chengdu, Sichuan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chengdu, Sichuan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.